NewRegulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
International Affairs Analyst (Remote) Amyand ConsultingInternational Affairs Analyst (Remote)San Francisco, CARemote$40,000–$45,000As a junior analyst, you will work closely with senior team members to support research projects, analyze data, and compile reports that assist in decision-making for our diverse range of clients. In this role, you will play a vital part in analyzing global trends, political developments, and economic conditions to provide insights that inform our consulting strategies.
Head of Global Affairs Common Sense Media, Inc.Head of Global AffairsSan Francisco, CA$175,000–$250,000 / yearWhat You'll Do: The Head of Global Affairs will work directly with the Office of the CEO's efforts to drive international technology policy and AI thought leadership for the organization, working with cross-functional leadership to build Common Sense's overall presence and relationships overseas with policymakers, educational leaders, advocacy partners, media platforms, and regional press. The Head of Global Affairs will help formulate and execute the Office of the CEO's strategy for Common Sense Media's global planning and growth to extend the organization's reach to better protect and prepare children, families, and our democracy in a digital world.
Government Affairs Intern Snowflake IncGovernment Affairs InternMenlo Park, CA$36–$50 / hourThis intern will support high-visibility engagements with congressional leaders, federal stakeholders, and state and local officials, helping Snowflake advance its policy priorities while gaining firsthand experience in how a leading technology company navigates the evolving regulatory and political landscape. Bonus Experience: Prior internship or project experience on Capitol Hill, in a federal agency, political campaign, think tank, trade association, or technology company government affairs office; familiarity with AI/data policy issues; demonstrated use of AI tools in an academic or professional context.
Regulatory Affairs Program Manager - Pleasanton, CA CalyxoRegulatory Affairs Program Manager - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearAs a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.
Manager, Public Affairs Abbott LaboratoriesManager, Public AffairsAlameda, CA$114,000–$228,000 / yearThe ideal candidate is a strong and passionate storyteller in consumer, tech, and health, and has a proven-track record of top-tier media placements, developing compelling messaging and PR content, building thought leadership, executive speaking engagements, and strategic communications, and managing issues. In partnership with Public Affairs colleagues in countries outside the U.S., support the development and execution of external public relations strategies and approaches for key product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming.
NewManager, Public Affairs AbbottManager, Public AffairsAlameda, CaliforniaIn partnership with Public Affairs colleagues in countries outside North America, support the development and execution of external public relations strategies and approaches for key product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. They should be adept at developing compelling messaging and PR content, building thought leadership, executive speaking engagements, and strategic communications, and managing issues.
Director of Clinical Affairs Endoluminal Intuitive Surgical IncDirector of Clinical Affairs EndoluminalSunnyvale, CAAs a key cross-functional constituent, this employee will work in a global matrix with teams across the Endoluminal Medical Officers, R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory compliance, Post Market Surveillance, Global Access Value Economics (GAVE), and Global Public Affairs (GPA) to optimize clinical evidence strategies to meet business priorities. The Director, Clinical Affairs- Endoluminal will guide, develop and execute long-range clinical trial strategies, inclusive of first human use, regulatory studies and post-market evidence generation and provide strategic guidance and oversight for global clinical evidence strategies for Intuitive's Endoluminal Business unit.
Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerSan Jose, CAThis 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.
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
Vice President, Ophthalmology Medical Affairs Annexon IncVice President, Ophthalmology Medical AffairsSan Francisco, CARemote$354,200–$377,000 / yearPosition: The Vice President, Ophthalmology Medical Affairs will be responsible for representing Annexon Biosciences with a network of external thought leaders and driving Global Medical Affairs activities in complement-mediated diseases in Ophthalmology. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.
Vice President, Medical Affairs - Neuroscience Annexon IncVice President, Medical Affairs - NeuroscienceSan Francisco, CARemote$354,300–$377,000 / yearPosition: The Vice President, Medical Affairs - Neuroscience will be responsible for representing Annexon Biosciences with a network of external thought leaders and driving Global Medical Affairs activities across complement-mediated neuroinflammatory and immunology-driven neurological diseases. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.
NewAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis PharmaAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998Palo Alto, CA$185,000–$205,000Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?
Executive Administrative Assistant to the Chief Strategy Legal Affairs Officer II-VI Optical Systems, Inc.Executive Administrative Assistant to the Chief Strategy Legal Affairs OfficerSanta Clara, CAWe are a vertically integrated manufacturing company that develops innovative products for diversified applications in the industrial, optical communications, military, life sciences, semiconductor equipment, and consumer markets. Support the CSLA leadership team, including leaders across Legal, Marketing, Communications, Government Affairs, Strategy and Global Affairs.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$80,000Ultimate Staffing Services is actively seeking a dedicated and detail-oriented Regulatory Affairs Associate to join a reputable medical device manufacturer. Coordinate, prepare, compile, and maintain regulatory documentation for local and regional registration, license renewal, and product submissions.
Director, Medical Affairs (Monarch Flexible Robotics) Johnson and JohnsonDirector, Medical Affairs (Monarch Flexible Robotics)Santa Clara, CAFull timeAct as a strategic partner with medical evidence generation colleagues in Preclinical Research, Clinical Development, and Health Economics Market Access teams to develop and execute global strategies for evidence generation for new and existing products to support regulatory approval/clearance, health technology assessment, customer access, and post-marketing support. Minimum of 7+ years relevant experience in post-graduate medical education ( beyond initial licensure ) including: specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or other related training/experience in Interventional Pulmonology required.
Executive Administrative Assistant to the Chief Strategy Legal Affairs Officer Coherent CorpExecutive Administrative Assistant to the Chief Strategy Legal Affairs OfficerSanta Clara, CAWe are a vertically integrated manufacturing company that develops innovative products for diversified applications in the industrial, optical communications, military, life sciences, semiconductor equipment, and consumer markets. Support the CSLA leadership team, including leaders across Legal, Marketing, Communications, Government Affairs, Strategy and Global Affairs.
Director of Clinical Affairs Intuitive Surgical IncDirector of Clinical AffairsSunnyvale, CAAs a key cross-functional constituent, this employee will work in a global matrix with teams across R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory Compliance, Post-Market Surveillance, Global Access Value Economics (GAVE), Global Public Affairs (GPA), and Medical officers to optimize clinical evidence strategies to meet business objectives. Direct leadership and management of clinical research infrastructure, including but not limited to development of clinical research protocols, case report forms, informed consent forms, management of trial master files, study-site assistance with IRB process and documentation preparation, study monitoring and investigator requirements, recruitment, and contracts preparation in conjunction with the clinical research team.
Staff Regulatory Affairs Engineer Hinge HealthStaff Regulatory Affairs EngineerSan Francisco, CaliforniaThe company has designed its platform to address a broad spectrum of MSK care—from acute injury, to chronic pain, to post-surgical rehabilitation—and the platform can help to ease members’ pain, improve their function, and reduce their need for surgeries, all while driving health equity by allowing members to engage in their exercise therapy sessions from anywhere. You will partner closely with Product, Clinical, and Engineering teams to interpret the evolving FDA framework for AI/ML, helping us navigate complex pathways like Predetermined Change Control Plans (PCCP).
Director, Regulatory Affairs Nova Pneuma IncDirector, Regulatory AffairsFremont, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CA$220,670–$259,610 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Scientific Director Senior Medical Director Medical Affairs - Global Oncology Pipeline Prostate Cancer AbbVie IncScientific Director Senior Medical Director Medical Affairs - Global Oncology Pipeline Prostate CancerSan Francisco, CAThe Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline provides medical and scientific input into core strategic and operational pipeline medical affairs activities for the prostate cancer portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
Scientific Medical Director Global Hematology Pipeline Medical Affairs AbbVie IncScientific Medical Director Global Hematology Pipeline Medical AffairsSan Francisco, CAThe Scientific/Medical Director, Global Hematology Pipeline, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities across the hematology pipeline including disease and asset strategy, scientific differentiation, value propositions, narratives and publication strategy, evidence generation and health-care professional and provider interactions. Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
Senior Manager Medical Affairs, Lingo Abbott LaboratoriesSenior Manager Medical Affairs, LingoAlameda, CA$130,700–$261,300 / yearThe Senior Manager, Medical Affairs will have expertise in cardiometabolic health (e.g., prediabetes, metabolic syndrome, obesity, nutrition, physical activity) and continuous monitoring devices or wearables to support activities (medical, scientific, and technical) across multiple global cross-functional teams (clinical, regulatory, R&D, marketing, sales, and quality), including development of relationships with key experts in the field and organization of advisory boards. Develop content appropriate for audience (e.g., internal leadership, cross-functional partners, external healthcare providers or scientists, consumers or users of Lingo products), which may include training materials, publications, conference summaries, symposiums, education workshops, or seminars.
Director, Regulatory Affairs Cytokinetics IncDirector, Regulatory AffairsSouth San Francisco, CA$225,000–$262,500 / yearCytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Qualifications: 10+ years of drug development, including at least 7+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development is preferred; experience in the cardiovascular therapeutic area is a plus.
Director/Senior Director, Regulatory Affairs SepternaDirector/Senior Director, Regulatory AffairsSouth San Francisco, CA$235,000–$285,000 / yearSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.
Sr. Regulatory Affairs TalentBurst, Inc.Sr. Regulatory AffairsSunnyvale, CAStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
NewSr. Regulatory Affairs - Contract TalentBurst, Inc.Sr. Regulatory Affairs - ContractSunnyvale, CAStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Senior Director, Regulatory Affairs Annexon IncSenior Director, Regulatory AffairsSan Francisco, CARemote$216,000–$241,000 / yearResponsibilities include: Provides regulatory leadership in support of the development, registration, and life-cycle management of Annexon products by collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studies. Responsibilities include developing and driving regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with regulatory agencies to support development and registration strategies.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Manager, Regulatory Affairs CMC Iovance Biotherapeutics IncManager, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Vice President, Regulatory Affairs Sight Sciences IncVice President, Regulatory AffairsMenlo Park, CAProven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting. He or she should know regulatory road maps for medical devices and preferably combination drug-device products, which will speed up the clinical trial cycle, the regulatory process and garner more government resources.
Associate Director, Regulatory Affairs CMC Iovance Biotherapeutics IncAssociate Director, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
NewSr Manager/Assoc Director, CMC Regulatory Affairs Erasca IncSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, CA$175,000–$205,000 / yearAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Position Responsibilities: Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations: Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
HP Corporate Affairs - Head of HP Solutions Comms HP IncHP Corporate Affairs - Head of HP Solutions CommsPalo Alto, CAThis role leads the HP Solutions Communications team and is accountable for driving stakeholder relationships, leading communication efforts for product launches, and trends, and driving key product PR strategies aligned with business objectives. As Director of HP Solutions Communications, you will lead the overall global HP Solutions business-partnering across Corporate Affairs, HPS, the markets, and corporate marketing to translate strategy into compelling communication strategies.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements: Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Sr. Project Manager, Clinical Affairs Intuitive Surgical IncSr. Project Manager, Clinical AffairsSunnyvale, CAAn ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management, providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans, including development roadmaps, governance forums, prioritization, and alignment with business units and other key stakeholders. Primary Function of Position: The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs.
Senior Project Manager, Clinical Affairs Intuitive Surgical IncSenior Project Manager, Clinical AffairsSunnyvale, CAAn ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management, providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans, including development roadmaps, governance forums, prioritization, and alignment with business units and other key stakeholders. Primary Function of Position: The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs.
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsSan Francisco, CA$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.
NewDirector, Quality & Regulatory Affairs Abbott LaboratoriesDirector, Quality & Regulatory AffairsLivermore, CA$172,000–$344,000 / year12+ years of progressive experience in healthcare regulatory compliance, accreditation, licensing, quality systems, or related disciplines, including direct people leadership experience with demonstrated success developing and managing high-performing teams. Acelis Connected Health (ACH) operates accredited Durable Medical Equipment (DME) and Independent Diagnostic Testing Facility (IDTF) businesses across all 50 states, supporting more than 80,000 patients through innovative connected healthcare solutions.
Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, CaliforniaAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)Alameda, CaliforniaCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Director, Quality & Regulatory Affairs AbbottDirector, Quality & Regulatory AffairsLivermore, California12+ years of progressive experience in healthcare regulatory compliance, accreditation, licensing, quality systems, or related disciplines, including direct people leadership experience with demonstrated success developing and managing high-performing teams. Acelis Connected Health (ACH) operates accredited Durable Medical Equipment (DME) and Independent Diagnostic Testing Facility (IDTF) businesses across all 50 states, supporting more than 80,000 patients through innovative connected healthcare solutions.
HP Corporate Affairs – Head of HP Solutions Comms HPHP Corporate Affairs – Head of HP Solutions CommsPalo Alto, CaliforniaThis role leads the HP Solutions Communications team and is accountable for driving stakeholder relationships, leading communication efforts for product launches, and trends, and driving key product PR strategies aligned with business objectives. As Director of HP Solutions Communications, you will lead the overall global HP Solutions business—partnering across Corporate Affairs, HPS, the markets, and corporate marketing to translate strategy into compelling communication strategies.
Senior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.