Regulatory Affairs Jobs in the United States
Medline Industries - Transportation & Operations
Northfield, IL
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. 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.
Daiichi Sankyo, Inc.
Bernards, NJ
CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
Jobot
$65000 - $93000
Bakersfield, CA
5* Develops and manages a comprehensive system for assessing organizational compliance and risk based upon clinical quality data and outcomes, concurrent observation of practices, tracer findings, mock survey findings, and actual survey findings. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Medline Industries - Transportation & Operations
Bloomington, MN
Complete 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.
Joulé
$100000 - $130000
Jersey City, NJ
We’re seeking a hands-on, proactive QA/RA Manager who thrives in a fast-paced, small-company environment and is ready to take ownership of Quality, Regulatory, and QC Laboratory oversight, including QC microbiology testing, LAL endotoxin testing, and overall QC compliance activities. This role is ideal for a driven leader who wants full visibility, autonomy, and impact across manufacturing, regulatory strategy, audits, and day-to-day quality operations.
TalentBurst, Inc.
$70 - $73
San Rafael, CA
Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings. The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the Client's regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
Jobot
$150000 - $200000
Sacramento, CA
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. If you're interested in learning more about this role please send a confidential email with a resume to: https://jobot.com/apply/government-and-regulatory-affairs-attorney/1227893360?utm_source=Monster.
Iconma
Marlborough, MA
Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables. Requirements:Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (7-10 years experience).
Daiichi Sankyo, Inc.
Bernards, NJ
Drives execution of all Global Medical Affairs Oncology activities as a member of GPT (Global Project Team) including giving medical inputs to TPP (Target Product Profile) and sponsored clinical trials in partnership with assigned Clinical Leader, and regional/country medical associates. May play a leadership role for the GMA Line function to drive an initiative or a project of importance for GMA May play site administrative or leadership role for GMA line function (i.e. Talent recruitment).
Daiichi Sankyo, Inc.
Bernards, NJ
Must have oncology experience, specifically in solid tumors •Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities •Demonstrated ability to lead and influence others internally and externally -Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions.
Daiichi Sankyo, Inc.
Washington, DC
Engage with trade and other membership organizations on priority issues, tracking developments and working to shape industry’s broader positioning to reflect Daiichi Sankyo’s business needs. Identify risks and opportunities and develop strategy for engagement on Daiichi Sankyo’s priority issues, collaborating with internal subject matter experts and aligning with leadership and Government Affairs & Public Policy team.
TalentBurst, Inc.
$70 - $75
Cambridge, MA
Exposure to Starting Point templates, SharePoint, EndNote, and Toolbox Pharma preferred Alignment with *** Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence. Bachelor's degree in a relevant scientific/technical field or equivalent experience 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within a regulatory environment.
Joulé
$195500 - $245600
Denver, CO
A well-established and growth-oriented medical device organization is seeking a strategic regulatory leader to guide global regulatory affairs and labeling strategy across a diverse product portfolio. Required Experience:10+ years of progressive regulatory affairs experience within medical devices (combination product experience strongly preferred).
Medline Industries - Transportation & Operations
Mundelein, IL
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Management of the recall team will include ensuring timely, compliant, and effective execution of recalls, corrections, and removals, while managing cross-functional teams and interfacing with regulatory authorities such as the FDA.Job Description.
Medline Industries - Transportation & Operations
Mundelein, IL
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Management of the risk management team will include ensuring that Medline’s processes (such as design and post market surveillance) have adequate risk management requirements built in that align to ISO 14971.Job Description.
LS Greenlink
Chesapeake, VA
We are currently seeking a Project Development Associate who will support the Managing Director of Corporate Affairs in coordinating project development activities, incentive programs, and pre-construction work for major capital investments. This role works collaboratively across internal teams and external partners to advance project planning, site selection, permitting, incentives, and due diligence efforts.
Fast Pace Health
Leesville, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
BESTMSLs
Los Angeles, CA
The individual engages with healthcare professionals (HCPs), key opinion leaders (KOLs), academic institutions, and other external stakeholders in a non-promotional, scientifically rigorous manner. A global biopharmaceutical organization is seeking an experienced Medical Science Liaison (MSL) at either the Associate Director or Director level to support its US Respiratory portfolio.
Flagstar Bank
$84878 - $112463
New York, NY
Supports the Commercial & Private Bank Business Risk & Controls Officer – Compliance Risk Officer in the interaction with the following Business Unit partners: Bank Examiners, External Bank Auditors, Enterprise Compliance & Risk Management, Internal Audit, Regulatory Affairs, Business Process Owners, and Shared Services organizations. Provides 1st Line with guidance with regard to the execution of Compliance Risk framework responsibilities with Business Process Owners including Enterprise Compliance Risk Assessments, Regulatory Compliance & Change Management, Customer Complaint Management, Compliance Testing, Issue Management, External Risk Events, Key Risk Indicators, Control Identification and Design, and Quality Assurance programs.
Flagstar Bank
$84878 - $112463
New York, NY
Consistently executes Risk & Control Self-Assessments, Issue Management, Internal Operational Risk Loss Events, External Risk Events, Key Risk Indicator, Control Identification and Design, and Quality Assurance programs while supporting the ongoing improvement and transformation of these areas. The Wealth Management – Flagstar Advisors Risk & Controls Associate will help to design, build, transform and implement a risk management framework and lead the ongoing identification, assessment, and measurement of the business line’s material risks and key controls.
CompuGroup Medical US
Austin, TX
Knowledge of health care legislation (HIPAA, HITECH, 21st Century Cures Act, Government payers, Billing and Participation, Stark Law, Anti-back Statutes, etc.) and the best practices to facilitate compliance with the requirements. At the powerful crossroads of healthcare and innovation, we are passionately building the next chapter of e-health—a revolution that saves lives, transforms care, and brings compassion into the digital age.
BESTMSLs
Orlando, FL
The Medical Science Liaison (MSL) will serve as the field-based scientific expert whose mission is to foster collaborative relationships with opinion leaders focused on a rare hematologic disorder and to facilitate the exchange of unbiased scientific information between the medical community and the company. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear.
BESTMSLs
Cleveland, OH
The Medical Science Liaison (MSL) will serve as the field-based scientific expert whose mission is to foster collaborative relationships with opinion leaders focused on a rare hematologic disorder and to facilitate the exchange of unbiased scientific information between the medical community and the company. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear.
Larimar Therapeutics
Philadelphia, PA
Collaborate with Market Access to ensure the field sales team follows the pull-through strategy and direction developed by Market Access, including any guidance related to Patient Services, while maintaining clear separation of roles and supporting cohesive execution. Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
Fast Pace Health
Manchester, TN
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
OneMain Financial
$80000 - $96000
Baltimore, MD
The leader will be responsible to collaborate with business, operations, product, and technology partners to deliver the engineering, systems integration and process improvement needs for all aspects of the Regulatory & Compliance support systems, inclusive of the day-to-day running of the engineering teams. Excellent verbal and written communication skills required for composing and delivering technical presentations or other forms of documentation to various level of technical and non-technical management.
T-Mobile USA, Inc
Bellevue, WA
As Senior Corporate Counsel, you'll be the go-to voice representing T-Mobile before state regulators-helping shape the policies that drive innovation, competition, and connectivity for our customers. At T-Mobile, employees in regular, non-temporary roles are eligible for an annual bonus or periodic sales incentive or bonus, based on their role.
Medline Industries - Transportation & Operations
Springfield, IL
At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). Act as a senior liaison with Divisions, Suppliers, Manufacturing, and Operations leadership to ensure quality products, timely.
Daiichi Sankyo, Inc.
Bernards, NJ
Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.
Daiichi Sankyo, Inc.
Bernards, NJ
Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities • Demonstrated ability to lead and influence others internally and externally • Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. Responsible for the development of the USOMA strategy and medical objectives for the assigned compound and leads development and execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Participates in Global Medical Affairs committees as requested.
Fast Pace Health
Jasper, TN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Carbon, IN
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Chattanooga, TN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Brazil, IN
Posting Title: Family Nurse Practitioner/Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Sinai Health System
Chicago, IL
The role also collaborates with Nursing leadership, Nursing staff and other patient care related services, as well as those in Quality/Performance Improvement roles to enhance the quality of Nursing practice using clinical data and the application of evidence-based practice. The Nursing Quality and Regulatory Compliance Manager is responsible for enhancing the clinical quality and outcomes of Nursing practice using clinical data and project planning, implementation, and evaluation by applying evidenced-based best practices throughout Sinai Chicago.
T-Mobile USA, Inc
Bellevue, WA
T-Mobile has an exciting opportunity for a Corporate Counsel to work in the Government Affairs Department, preferably in our Bellevue, Washington office, though consideration will be given to candidates who prefer to be located in our Overland Park, KS or Herndon, VA offices. Participate in state regulatory proceedings relevant to T-Mobile's interests, with a particular focus on matters before state public utilities' commissions, including the California Public Utilities Commission.
Carl Zeiss Meditec, Inc
$183000 - $228800
Seattle, WA
The individualis responsible forregulatory strategy andsupportofa variety of FDA submissionsincluding pre-submissions (Q-subs), pre-market notifications(510(k)s), pre-market approvalapplications (PMAs)andinvestigational device exemptions (IDEs). This roleacts as an advisorand subject matter expertfor US regulatoryand clinicalquestions, specifically interpreting US FDA's perspective,at all levels, from senior management to single contributors;for all functions (e.g.
Daiichi Sankyo, Inc.
Bernards, NJ
The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Fast Pace Health
Custer, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Guston, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Salem, IN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Muldraugh, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Guston, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
AVTEC FINISHING
$140000 - $150000
New Hope, MN
Position: General Manager - Metal Plating/FinishingCompany: Avtec Finishing / New Hope MNShift: Days - Exact Hours To Be DeterminedWage: $140,000 - $150,000Signing Bonus: $1500 (new hires only). WHAT WE'RE LOOKING FORBachelor's degree in business, engineering, manufacturing, finance, or equivalent, or 5 years experience in management position in the metal finishing industry - preference for experience managing a plating facility.
Chemtall/ SNF Holding
null, GA
While the Integrated Management System (IMS) is owned by the Responsible Care® organization, this role serves as a critical Quality partner, responsible for quality investigations, customer complaints, CAPA effectiveness, performance metrics, and IMS audit execution. Strong working knowledge of ISO 9001, ISO 14001, and RC14001, with demonstrated experience implementing and sustaining management systems; Certified Lead Auditor strongly preferred.
DLA Piper LLP (US)
$168478 - $272949
Seattle, WA
While the specific job requirements of a DLA Piper position may vary depending upon scope of the job and area of specialty, there are certain universal requirements that are expected of all DLA Piper employees, which include but are not limited to: Effectively communicate, verbally and in writing, with clients, lawyers, business professionals, and third parties. Prior substantive legal experience in one or more of the practice's subgroups, including Data Protection, Privacy & Security; Environmental; FDA Regulatory; Financial Regulatory & Technology; Government Affairs & Public Policy; Government Contracts; Healthcare Regulatory; National Security & Global Trade; Telecom; and Transportation Regulatory.
DLA Piper LLP (US)
Seattle, WA
This position can sit in our Atlanta, Austin, Baltimore, Boston, Tampa, Chicago, Dallas, Houston, Los Angeles, Miami, Minneapolis, New York, Northern Virginia, Philadelphia, Phoenix, Raleigh, San Diego, Seattle, Short Hills, Washington D.C., or Wilmington office and offers a hybrid work schedule. As a member of the Business Development's Pitch & Proposal team, the Pursuits & Directories Sr Coordinator - Regulatory & Government Affairs, has a primary responsibility for assisting the Firm win new business through the development of compliant, on-time, best-in-class and client-centric formal RFP responses and pitch responses.
System One
$85000
21702, Virginia
Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file. -Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file.
Flagstar Bank
$84878 - $112463
New York, NY
Reviews various reports including check fraud, significant activity, significant change, large deposit, detailed transaction report and month-end reports; investigate & approve when needed. Develops and expands existing relationships including sales efforts; engages key Product Partners as appropriate in delivering the full breadth of the bank to satisfy clients needs.
Vaco LLC
$45 - $55
New York, NY
Partner with CLAO on management of Board and related committees; Review and/or prepare for filing various financial reporting documents, such as the Form 990 and state registration forms, filings relating to lobbying compliance, filings relating to governmental pre-qualifications and filings due to watchdog agencies, such as the Better Business Bureau; Develop and deliver trainings and workshops for staff; Monitor and advise the CLAO and others on legislative developments related to nonprofit organizations, including human resources and benefits-related legislation; and. This will include reviewing, drafting, and negotiating contracts and other documents, such as: sponsorship agreements, grant agreements, non-disclosure agreements, consulting agreements, and licenses and releases, and advise senior management on related issues; Assist CLAO in ensuring organizational compliance with applicable laws and regulations, such as lobbying, regulatory and public policy matters, and laws relating to charitable solicitations in New York State and nationally; Advise on risk management practice, liability, and insurance matters; Prepare materials for Board and committee meetings.