Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Affairs Lead, Class III Medical Devices

BioTalent

BioTalent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment. The role centers on leading FDA submissions (including PMAs), global registrations, and guiding design controls, risk management, and product commercialization throughout development. #J-18808-Ljbffr BioTalent

Vacancy posted 5 hours ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead, Class III Medical Devices in Oklahoma City, OK vacancy
  • Our client, an innovative medical device company, is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy and submissions for complex Class III products. This is a hands-on role...  ...regulatory professional who can both lead and execute. The successful... 
    Senior
    Medical device
    Shift work

    BioTalent

    Oklahoma City, OK
    15 hours ago
  •  ...and execute global regulatory strategies for...  ...conformity assessments). Lead regulatory risk...  ...the Regulatory Affairs function on...  ...new and existing devices. Lead and influence...  ...experience within the medical device industry...  ...experience with Class I/II/III/IV software... 
    Senior
    Medical device
    Work at office

    Jobtailor

    Oklahoma City, OK
    3 days ago
  •  ...Life Sciences is seeking an experienced QC Analyst III to join our GMP-regulated Quality Control team. The role leads analytical testing across early development to...  ...manufacturing, ensuring data integrity and regulatory compliance. You will work with HPLC/UPLC, GC, UV... 
    Senior

    Meet Life Sciences

    Oklahoma City, OK
    2 days ago
  • Philips is seeking a Senior Quality Operations Manager-Advanced Imaging in Bedford, MA to lead quality operations for medical devices. The role drives CAPA/NC/QN processes, process...  ...coordinating across R&D, manufacturing, and regulatory affairs to uphold regulatory standards and... 
    Senior
    Medical device

    Mass Digital Health

    Oklahoma City, OK
    4 days ago
  • Mass Digital Health is looking for a Senior Regulatory Affairs Specialist to support Ultrasound...  ...guiding cross-functional teams, and leading regulatory intelligence initiatives....  ...have over 5 years of experience in medical device regulatory affairs, with expertise in... 
    Medical device
    Work at office

    Mass Digital Health

    Oklahoma City, OK
    2 days ago
  •  ...What You’ll Do Leading PMA supplements, IDEs, and/or 510(k) submissions Owning regulatory strategy for product changes and lifecycle...  ...: 5+ years of Regulatory Affairs experience in medical devices Direct hands-on...  ...currently operating at a Senior level and ready for greater... 
    Senior
    Medical device
    Remote work

    Pragmatic

    Oklahoma City, OK
    15 hours ago
  • Avalyn Pharma is seeking a Senior Manager, Regulatory Affairs to shape global regulatory strategy for inhaled drug-device products. You will lead regulatory submissions, health authority interactions, and cross‑functional planning from early development through late-stage... 
    Senior
    Remote job

    Avalyn Pharma

    Oklahoma City, OK
    2 days ago
  • Philips in Bedford, MA is seeking a Senior Quality Manager-Advanced Imaging to lead the QMS and design assurance...  ...product lifecycle. You will guide regulatory readiness, oversee audits, and...  ...continuous improvement in a regulated medical device environment. The role requires 8... 
    Senior
    Medical device
    Work at office

    Mass Digital Health

    Oklahoma City, OK
    2 days ago
  • $94k - $150k

    Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist, Ultrasound...  ..., Declarations of Conformity, and Medical Device Licenses—for various global markets....  ...major changes to existing products. Lead global regulatory intelligence initiatives... 
    Senior
    Medical device
    Full time
    Work at office
    Work visa
    Relocation package
    3 days per week

    Mass Digital Health

    Oklahoma City, OK
    4 days ago
  • $120k - $140k

     ...seeking a Program Manager for their Beverly, MA location in the medical device sector. The Program Manager will oversee product development...  ...budgets, and mentor teams while ensuring compliance with regulatory standards. This role requires over 8 years of experience in the... 
    Senior
    Medical device

    Freudenberg Group

    Oklahoma City, OK
    2 days ago
  • Olympus Corporation in the United States seeks a senior Product Marketing leader for Swan Endosurgical Alliance to drive upstream...  ...commercialization. The role requires a strong track record in medical devices marketing, launch planning, and stakeholder communication... 
    Senior
    Medical device

    Olympus Corporation

    Oklahoma City, OK
    2 days ago
  • $134k - $213k

    Senior Quality Operations Manager-Advanced Imaging...  ...ensuring compliance with regulatory standards and...  ...manufacturing, and regulatory affairs to address process...  ...products/services, often leads a cooperative effort among...  ...regulated (ISO 13485) medical device quality operations/... 
    Senior
    Medical device
    Full time
    Work at office
    Local area
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Mass Digital Health

    Oklahoma City, OK
    4 days ago
  •  ...: Why Merit? At Merit Medical, our mission is to create...  ...innovative medical devices that improve lives. Our...  ...developing best in class quality systems. Coordinates...  ..., international regulatory affairs/quality assurance, and...  ...their jobs. Risk category III states employment and... 
    Senior
    Medical device
    Local area
    Shift work
    Night shift

    Merit Medical Systems, Inc.

    Oklahoma City, OK
    2 days ago
  • Jobtailor is seeking an experienced Regulatory Affairs professional to develop and execute global regulatory strategies for medical devices, including software-based solutions. You will lead submissions and agency interactions across FDA, EU MDR, NMPA, PMDA, and TGA. Collaborate... 
    Medical device

    Jobtailor

    Oklahoma City, OK
    2 days ago
  •  ...compliance matters, and counseling business leads across the globe on a wide‑range of...  ...clients is a must. Job Details Seniority level: Associate Employment type: Full...  ...firm and in‑house experience preferred. Medical device or other regulated industry experience.... 
    Senior
    Medical device
    Full time

    New England Legal Search

    Oklahoma City, OK
    1 day ago
  •  ...Senior Director of Strategic Alliances About the Company A contract development and manufacturing company serving medical device OEMs. Industry Medical Devices Type Privately Held About the Role The Company is seeking a Senior Director of Strategic... 
    Senior
    Medical device
    Contract work

    Confidential

    Oklahoma City, OK
    15 hours ago
  • $151k - $215k

     ...do. As part of our Medical Affairs team, you'll...  ...inspiring journey. The Senior Principal...  ...trial designs to regulatory submissions while...  ...make an impact: Lead end-to-end evidence...  ...Preferred): Medical device industry experience...  ...technologies, world-class evidence and... 
    Senior
    Medical device
    Full time
    Remote work

    Edwards Lifesciences

    Oklahoma City, OK
    4 days ago
  • Devon is seeking a Lead Financial Reporting Accountant in Oklahoma City to independently manage the preparation, analysis, and distribution of monthly, quarterly, and annual financial statements for internal and external use. You will ensure GAAP and SEC compliance while... 
    Senior

    FHLB Des Moines

    Oklahoma City, OK
    4 days ago
  • $220k - $260k

     ...annually Job Title: Senior Medical Director -...  ...Medical Director to lead the clinical development...  ...for a first-in-class therapeutic candidate...  ...medical and regulatory oversight. You will...  ...Disease, US Medical Affairs Vice President International...  ...and Medical Devices Vice President,... 
    Senior
    Medical device
    Full time
    Remote work

    Lumicity

    Oklahoma City, OK
    1 day ago
  •  ...Affordable in MA is seeking an Affordable Housing Compliance Specialist to ensure adherence to HUD, LIHTC, PBS8, PBV, RAD, and related regulatory agreements. Located in Massachusetts, reporting to the Director of Regulatory Compliance, the role requires attention to detail... 
    Senior

    Limitless Decatur

    Oklahoma City, OK
    3 days ago
  • Prism Bank is seeking a senior BSA/AML Compliance Officer to lead the Bank's anti-money laundering program and regulatory risk management. The role emphasizes expertise in Verafin analytics, SAR/CTR reporting, and enterprise-wide risk assessments across departments. You... 
    Senior

    Prism Bank

    Oklahoma City, OK
    5 hours ago
  • • Partner with the Device Regulatory Lead on assigned projects • Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross...  ...• Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices... 
    Senior
    Medical device

    Jobtailor

    Oklahoma City, OK
    3 days ago
  • Devon is seeking a Lead Financial Reporting Accountant to independently lead monthly, quarterly, and annual financial reporting with strong GAAP and SEC focus. You will liaise with external auditors, mentor staff, and drive improvements in reporting processes to support... 
    Senior

    Oil Authority

    Oklahoma City, OK
    1 day ago
  • Harvard University’s Office of Research and Academic Compliance seeks a Research and Academic Compliance Officer (RACO) to manage cross-school risk and compliance in areas including conflicts of interest, export controls, and international collaborations. The role advises...
    Senior
    Work at office

    Harvard University

    Oklahoma City, OK
    1 day ago
  • Northrop Grumman seeks an FSO/Sr. Principal Industrial Security Analyst 4 for the Oklahoma City, OK site. Lead and execute the facility's industrial security program, ensure NISPOM compliance, and collaborate with program management, contracts, HR, and government customers... 
    Senior

    Northrop Grumman

    Oklahoma City, OK
    2 days ago
  • Lead the end-to-end copy review process for educational and commercial materials...  ...Partner with Marketing, Medical Affairs, Legal, and Regulatory stakeholders to align messaging and...  ...understanding of healthcare, medical device, or life sciences industry standards... 
    Senior
    Medical device

    Jobtailor

    Oklahoma City, OK
    4 days ago
  • Prism Bank seeks a seasoned Compliance Officer to lead CRA, HMDA, and Consumer Compliance programs. You will oversee data collection...  ...reporting, coordinate examinations, and drive improvements in regulatory readiness across the bank. The role requires extensive experience... 
    Senior
    Full time

    Prism Bank

    Oklahoma City, OK
    1 day ago
  • United Overseas Bank Limited is seeking an Assistant Vice President for the Specialised Investigations Team to lead complex Anti-Financial Crime investigations and coordinate with compliance, risk and business units. The role emphasizes applying advanced analytics to detect... 
    Senior
    Overseas

    United Overseas Bank Limited

    Oklahoma City, OK
    3 days ago
  • Jobtailor in Massachusetts seeks a senior Copy Review Lead to oversee end-to-end review of educational and promotional materials...  ..., and consistency. You will partner with Marketing, Medical Affairs, Legal and Regulatory to align messaging and streamline approvals, while mentoring... 
    Senior

    Jobtailor

    Oklahoma City, OK
    4 days ago
  •  ...role drives growth through strategic planning, leadership, and business development, requiring extensive sales experience in the medical device industry. Your responsibilities include developing business plans and overseeing a sales team while fostering key client... 
    Senior
    Medical device

    LifeNet Health

    Oklahoma City, OK
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead, Class III Medical Devices. Be the first to apply!