Engineer, Principal Regulatory Constellation EnergyEngineer, Principal RegulatoryWarrenville, IL$152,100–$169,000Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies.
Associate Director, Regulatory Affairs - Advertising & Promotion Xeris Biopharma Holdings IncAssociate Director, Regulatory Affairs - Advertising & PromotionChicago, IL$174,000–$232,000 / yearSignificant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials. Provides leadership for and manages regulatory aspects of the copy review / approval process for promotional materials; ensures compliance of promotional materials with FDA laws, regulations, and published guidance documents.
Regulatory Affairs Specialist Sterigenics U.S.Regulatory Affairs SpecialistOak BrookWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Associate Director International Regulatory Affairs Advertising & Promotion-Hybrid AbbVie IncAssociate Director International Regulatory Affairs Advertising & Promotion-HybridILThe Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Senior Associate, Regulatory Affairs (Hybrid) ICU Medical IncSenior Associate, Regulatory Affairs (Hybrid)Lake Forest, IL$97,500–$139,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
NewSenior Associate, Regulatory Affairs ICU Medical IncSenior Associate, Regulatory AffairsLake Forest, IL$97,500–$139,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
Associate Director International Regulatory Affairs Advertising & Promotion AbbVie IncAssociate Director International Regulatory Affairs Advertising & PromotionILThis individual is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerChicago, ILThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Manager Food Safety Quality & Regulatory Affairs (Foreign Material and Operational) Conagra Brands IncManager Food Safety Quality & Regulatory Affairs (Foreign Material and Operational)Chicago, IL$109,000–$159,000 / yearWhen visiting these sites, the physical requirements below may apply: You may be required to walk around the facility, climb stairs/ladders, kneel, or perform repetitive tasks that require hand-eye coordination. We care about your total well-being and will support you with the following, subject to your location and role: Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement.
Senior Manager - Regulatory Affairs Covista IncSenior Manager - Regulatory AffairsChicago, IL$80,336.75–$145,077.09 / yearUnder the general direction of the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for ensuring that all Covista advertising, marketing, public- and student-facing communications for all Covista institutions and business units are written in compliance with state and federal regulatory agency requirements. Due to the importance, high visibility of marketing, risks and potential impact related to misrepresentation, the incumbent must have the business acumen to accurately interpret often ambiguous regulations and partner with marketing and operations leaders to accept guidance on marketing practices.
NewSr Regulatory Affairs Specialist- Medical Devices SunstarSr Regulatory Affairs Specialist- Medical DevicesSchaumburg, IllinoisWork with Regional Director, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements. Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.
Regulatory Affairs Specialist Sotera Health CoRegulatory Affairs SpecialistOak Brook, IL$63,000–$95,000 / yearWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Senior Regulatory Affairs Specialist Conagra Brands IncSenior Regulatory Affairs SpecialistChicago, IL$82,000–$120,000 / yearWe care about your total well-being and will support you with the following, subject to your location and role: Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement. Our focus on innovation extends beyond making great food, it also reflects our commitment to embracing new solutions that positively impact our team, the communities we serve and the health of our planet.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyILApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Manager Kobayashi Healthcare International IncRegulatory Affairs ManagerNiles, ILEnsure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications. Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
Manager, Regulatory Affairs Xeris Biopharma Holdings IncManager, Regulatory AffairsChicago, IL$120,000–$165,000 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. This role will be responsible for preparing and reviewing regulatory submissions, contributing to regulatory strategy, and interacting with internal and external stakeholders to ensure compliance with global health authority requirements.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisThe ideal candidate brings deep expertise in Medicare and individual insurance compliance, strong regulatory knowledge, and experience building scalable compliance frameworks within complex, multi-site insurance or healthcare environments. This role will lead the development, implementation, and oversight of scalable compliance programs supporting Medicare Advantage, Medigap, Part D, ACA, and ancillary insurance products across a national distribution platform.
Director Regulatory Affairs Dairy Management Inc.Director Regulatory AffairsRosemont, IL$99,000–$120,000The Director will lead day-to-day regulatory affairs activities, working cross-functionally with regulatory, scientific, nutrition and sustainability affairs, marketing and communications, global and domestic partnerships, product research and development and nutrition research teams to ensure that dairy foods are accurately, credibly and compellingly represented in the health and wellness marketplace. Additionally, the Director will support DMI’s engagement with the broader regulatory community by monitoring policy developments, contributing technical expertise to industry discussions and collaborating with leading organizations to help ensure dairy is appropriately represented within evolving food and nutrition and regulatory frameworks.
Regulatory Affairs Manager, Comprehensive Cancer Center University of ChicagoRegulatory Affairs Manager, Comprehensive Cancer CenterChicago, IL$65,000–$90,000 / yearActs as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments; review of site consent forms; collection of site specific essential documents, including IRB approvals, Form FDA 1572, staff qualifications and signatures, etc. and maintenance of up-to-date regulatory files for external participating sites. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts.
Regulatory Affairs Specialist - Medical Device iMPact Business GroupRegulatory Affairs Specialist - Medical DeviceCary, ILEvaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans or strategies for changes that do not require submissions. Evaluating the regulatory environment and contributing to internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Sr Mgr, Regulatory Affairs Baxter International IncSr Mgr, Regulatory AffairsDeerfield, IL$152,000–$209,000 / yearYour role at BaxterA Senior Manager of Global Regulatory Affairs leads the development and execution of regulatory strategies to support product approvals, lifecycle management, and compliance across international markets, with deep expertise in US FDA requirements. Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
Regulatory Affairs Specialist Medline Industries LPRegulatory Affairs SpecialistIL$79,000–$119,000 / yearPrepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaIL$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Regulatory Affairs Specialist, North America Barry Callebaut AGRegulatory Affairs Specialist, North AmericaChicago, ILAbout the role: Barry Callebaut is a global organization poised for growth; a company which has embraced the vision to delight its customers, while out-performing its competitors, a business which is committed to sustainability, has innovation in its DNA, is a leader in complex manufacturing and supply chain solutions and is focused on being a best-in-class employer. This role partners closely with cross-functional teams-including Quality, CI&TS, Marketing, and Sales to identify regulatory risks, support product development, and maintain documentation that enables on-time product launches and compliant market access.
Regulatory Affairs Specialist JBL ResourcesRegulatory Affairs SpecialistCary, ILJBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Regulatory Affairs Director IQVIA Holdings IncRegulatory Affairs DirectorRosemont, IL$128,800–$358,800 / yearThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
Sr Spec Regulatory Affairs Medline Industries LPSr Spec Regulatory AffairsIL$92,000–$138,000 / yearComplete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Senior Regulatory Affairs Specialist Medline Industries LPSenior Regulatory Affairs SpecialistIL$92,000–$138,000 / yearComplete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistDes Plaines, IL$38–$43 / hourIn this role, you won't just maintain compliance-you'll drive registrations, build and manage dossiers, interface with agencies, and influence regulatory strategy across products that support animal health, food safety, and global dairy production. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
NewRegulatory Affairs Manager (Hybrid) ICU Medical IncRegulatory Affairs Manager (Hybrid)Lake Forest, IL$112,500–$161,250 / yearProvides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management.
Regulatory Affairs Specialist III - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Specialist III - Diabetes Care (on-site)Buffalo Grove, IL$68,000–$136,000 / yearProvides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Regulatory Affairs Specialist III – Diabetes Care (on-site) AbbottRegulatory Affairs Specialist III – Diabetes Care (on-site)Buffalo Grove, IllinoisProvides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Director, Regulatory Affairs Jupiter Power LLCDirector, Regulatory AffairsChicago, IL$160,000–$180,000 / yearIn this role, you will be responsible for tracking and communicating regulatory requirements for Jupiter's entities and resources to participate in markets and will be responsible for working closely with cross-functional teams to ensure regulatory developments, project requirements, and market opportunities are effectively analyzed and communicated. Lead regulatory tracking and internal communication of requirements necessary for execution of regulatory activities supporting project development, i.e. filings for capacity market participation, interconnection processes, and other market-related requirements.
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsChicago, IL$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern's existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern's engagement in regulatory and market design changes, develop Pattern's positions and execute on strategies to achieve desired objectives.
Senior Analyst - Regulatory Affairs Covista IncSenior Analyst - Regulatory AffairsChicago, IL$49,199.33–$86,253.75 / yearCovista is the parent company of American University of the Caribbean School of Medicine, Chamberlain University, Ross University School of Medicine, Ross University School of Veterinary Medicine and Walden University. Our colleagues come from a wide range of backgrounds, business, academia, healthcare, government and nonprofits, and are part of a culture where doing exceptional work and making a meaningful difference for students and society aren"t separate goals-they"re one and the same.
Senior Staff Specialist, Regulatory Affairs Roth Staffing CompaniesSenior Staff Specialist, Regulatory AffairsCary, Illinois$55–$64.45 / hourEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze and validate potentially complex and dynamic material.
Senior Staff Specialist, Regulatory Affairs Apidel TechnologiesSenior Staff Specialist, Regulatory AffairsCary, ILContractorDemonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution. Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteChicago, ILRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Lead, State Affairs - West The Kraft Heinz CoLead, State Affairs - WestIL$141,500–$176,900 / yearDemonstrated SME depth in at least two areas relevant to KHC (e.g., food safety/labeling; agriculture and nutrition programs; packaging/EPR; tax/incentives; workforce/labor; environment/climate; privacy/data), evidenced by authored comments/testimony or task force participation. Required Experience: 8+ years in state government (legislature, governor/AG office, or state agency) or state lobbying experience Proven record drafting/negotiating legislation and regulations, delivering testimony, and securing enactments or defeating adverse proposals.
Manager of Government Affairs & Policy Metropolitan Family ServicesManager of Government Affairs & PolicyChicago, IllinoisReporting to the Vice President of Policy and Government Affairs, the Manager supervises Government Affairs & Policy Associates and Policy Analysts (and if applicable, interns) and ensures effective coordination and collaboration across departmental and agency-wide policy development, research, advocacy communications, and legislative engagement efforts. Metropolitan is Illinois’ first comprehensive human services agency and reaches more than 205,000 individuals and families in Chicago, Evanston/Skokie, the southwest suburbs and DuPage County with services promoting education, economic stability, emotional wellness and empowerment.
NewSenior Manager/Associate Director, Environmental Affairs Cypress Creek Renewables LLCSenior Manager/Associate Director, Environmental AffairsChicago, ILProvide subject matter expertise support during financing, which would include responding to Independent Engineers and external legal counsel comments, advising on contractual terms and conditions for environmental risk, and supporting internal legal, tax, and finance teams to compile environmental documentation. Directly oversee scoping and managing complex, environmental regulatory compliance processes, such as targeted environmental resource studies (e.g., wetland delineations, Phase I ESAs, cultural resource surveys), environmental permitting, and mitigation negotiation, within the Company and with outside consultants.
VP-Academic Affairs City Colleges of ChicagoVP-Academic AffairsChicago, ILAs the Chief Academic Officer, the Vice President provides strategic leadership for a college's instructional functions, working collaboratively with senior administrative staff to develop and implement innovative approaches to enhance academic excellence and provide students with innovative and effective learning experiences. Partners with fellow college and district leaders in development and implementation of college plans to ensure continuous and measurable improvement in student life cycle benchmarks including enrollment, academic progression, persistence, retention, completion, and post-completion success.
Medical Affairs Scientific Communications Director - Movement Disorders H. Lundbeck ASMedical Affairs Scientific Communications Director - Movement DisordersDeerfield, ILRemoteThis individual will partner closely with HEOR, Commercial, Customer insights & analytics, Patient advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure scientific materials are accurate, balanced, compliant, and aligned with medical objectives while serving as a scientific communications expert across the organization. SUMMARY: The Medical Affairs Scientific Communications Director will lead the strategic development and execution of scientific communication plans for MSA that support launch readiness and are aligned with the needs of patients, caregivers, healthcare professionals, payers, and policymakers.
Regional Medical Affairs Manager Photocure ASARegional Medical Affairs ManagerChicago, ILPhase 4) studies Provide input into study protocols, investigator brochures, statistical analysis plans, and clinical study reports Drive study timelines, budgets, and milestones to ensure successful delivery Lead site identification, feasibility assessments, and Site Initiation Visits (SIVs) Support onboarding and training of investigators and study staff Act as primary sponsor representative for CROs and vendors Help manage vendor performance, timelines, and deliverables Contribute to the management of sponsor studies, investigator-initiated studies (IIS/IITs), research collaborations from a scientific and operational perspective Support ongoing registry programs with a focus on data quality and site performance. Key Responsibilities and Activities: External Expert Engagement: Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs) Develop and participate in medical communication, education and training for KOLs Identify data gaps related to disease area or products based on clinical insights Participate in local and national congresses Assist in the development, implementation, and delivery of Medical Advisory Boards.
Lead, State Affairs – Remote Hybrid within Western Region Kraft HeinzLead, State Affairs – Remote Hybrid within Western RegionChicago, IllinoisRemoteDemonstrated SME depth in at least two areas relevant to KHC (e.g., food safety/labeling; agriculture and nutrition programs; packaging/EPR; tax/incentives; workforce/labor; environment/climate; privacy/data), evidenced by authored comments/testimony or task force participation. We spark joy around mealtime with our iconic brands, including Kraft, Oscar Mayer, Heinz, Philadelphia, Lunchables, Velveeta, Planters, Maxwell House, Capri Sun, Ore-Ida, Kool-Aid, Jell-O, Primal Kitchen, and Classico, among others. .
SVP, Public Affairs AvqSVP, Public AffairsChicago, IL$215,000Maintaining a diverse staff of first-class talent (including those from BIPOC, LGBTQ communities, and others from historically underrepresented groups), and conferring a sense of value and belonging on each team member is central to our mission as expert communicators and advocates. Has experience with political, policy, or corporate advocacy communications and campaigns, including experience with brand marketing, media planning and analytics, audience targeting, integrated marketing and thought leadership strategies.
NewSr. Director, Clinical Affairs Sysmex America IncSr. Director, Clinical AffairsIL$210,000–$330,000 / yearEnsure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
NewDirector, Clinical Affairs Sysmex America IncDirector, Clinical AffairsIL$168,490–$264,000 / yearEnsure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
Manager, Government Affairs Pattern Energy Group IncManager, Government AffairsChicago, IL$103,000–$138,000 / yearIntegrates input from development, operations, and commercial teams, as well as executive leadership, to identify policy-driven risks and opportunities, and to articulate the company''s positions on key issues; leads internal teams in prioritizing and analyzing the impact of critical legislative and regulatory issues based on the company's business plan; reports on key issues and impacts to relevant internal staff and executive management team. Additionally, the role will need to manage multiple initiatives at once and work closely with the development and other departments to design and execute comprehensive external affairs strategies to achieve desired policy outcomes to support the company's commericial objectives.
NewDirector, Clinical Affairs SysmexDirector, Clinical AffairsLincolnshire, Illinois$168,490–$264,000 / year4. Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.