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

Senior Regulatory Affairs Lead - Medical Devices

PDDN INC.

PDDN INC. is seeking a Principal Regulatory Affairs Specialist to lead post-market regulatory activities in a hybrid Maple Grove setting. The role requires deep knowledge of FDA and international regulations, plus the ability to drive CAPA programs and regulatory submissions. You will collaborate with Quality, Engineering, and Commercial teams across the product lifecycle. Ideal candidates have 12+ years in regulatory affairs within medical devices, strong communication skills, and experience #J-18808-Ljbffr PDDN INC.

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead - Medical Devices in Osseo, MN vacancy
  • $109k - $174.8k

     ...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory...  ...is currently seeking a Sr Program Lead, Regulatory Affairs to join our team...  ...submissions and EU Technical Document for medical devices for commercialization in the USA.... 
    Senior
    Medical device
    Full time
    Temporary work
    Local area
    Worldwide

    Johnson & Johnson Innovative Medicine

    Plymouth, MN
    2 days ago
  • $109k - $174.8k

     ...Sr Program Lead, Regulatory Affairs Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team...  ...0K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA. Generates... 
    Senior
    Medical device
    Temporary work
    Local area
    Worldwide

    J&J Family of Companies

    Minneapolis, MN
    22 hours ago
  • ManpowerGroup Global, Inc. in Maple Grove, MN, seeks a Regulatory Affairs Program Manager to lead large-scale regulatory programs across medical device businesses. The role demands strong program management, cross-functional leadership, and execution from planning through... 
    Medical device

    ManpowerGroup Global, Inc.

    Osseo, MN
    5 days ago
  •  ...whatever your ambitions. Senior Legal CounselAbout the...  ...managing legal and regulatory risk. You will also help...  ...be opportunities to lead or participate in broader...  ..., and Regulatory Affairs.Advise on FDA, FTC and...  ...guidance affecting the medical device industry.Participate in... 
    Senior
    Medical device
    Hourly pay
    Fixed term contract
    Work at office
    Local area
    Shift work
    3 days per week

    Boston Scientific Corporation

    Maple Grove, MN
    2 days ago
  • TALENT Software Services is seeking a Senior Chemist to join the PVH R&D team. This role focuses on developing, characterizing, and validating medical device products for venous disease, with emphasis on chemistry support for released and emerging products. You will collaborate... 
    Senior
    Medical device

    TALENT Software Services

    Minneapolis, MN
    5 days ago
  •  ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough...  ...business provides proven, leading solutions to treat several...  ...relationships with device reviewers through oral and...  ...related discipline within the medical device industry, including... 
    Senior
    Medical device
    Work at office
    Local area
    3 days per week

    Boston Scientific

    Maple Grove, MN
    1 day ago
  • Integer Holdings is seeking a senior regulatory affairs professional to develop and manage US and international regulatory strategies for medical device submissions. You will prepare submissions, interact with FDA/other agencies, and serve as a cross‑functional regulatory... 
    Senior
    Medical device

    Integer Holdings

    Minneapolis, MN
    22 hours ago
  • $75.3k - $150.7k

     ...Senior Regulatory Quality Specialist Abbott is a global healthcare leader...  ...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic...  ...development/support, scientific affairs, operations, or related area.... 
    Senior
    Medical device
    Work experience placement
    Shift work

    Abbott

    Maple Grove, MN
    5 days ago
  • Abbott, a global healthcare leader, seeks a Senior Clinical Quality Associate for our Maple Grove, MN site (hybrid opportunities may...  ...exist). The role focuses on ensuring compliance with GCP and medical device regulations across global clinical teams. Responsibilities include... 
    Senior
    Medical device
    Work at office
    Relocation

    Abbott

    Osseo, MN
    4 days ago
  • Senior Regulatory Affairs Specialist - Medical Devices About the Role We are seeking a Senior Regulatory Affairs Specialist to support global regulatory activities for medical devices. This role partners with cross‑functional teams to develop regulatory strategies, prepare... 
    Senior
    Medical device

    ACE Partners

    Minneapolis, MN
    4 days ago
  • Medtronic plc is seeking a Senior Regulatory Affairs Specialist to lead worldwide product registrations. The role focuses on preparing submissions to...  ...contribute to the global regulatory strategy for high-risk medical devices, leveraging your experience to ensure timely market... 
    Medical device
    Worldwide

    Medtronic plc

    Minneapolis, MN
    1 day ago
  • $94k - $150k

    Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory...  ...Specialist, UltrasoundThe Senior Regulatory Affairs Specialist...  ...of Conformity, and Medical Device Licenses—for various global...  ...changes to existing products.Lead global regulatory intelligence... 
    Senior
    Medical device
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Plymouth, MN
    2 days ago
  • We’re partnered with a mid-size Class II Medical Device business looking for a Senior Regulatory Affairs Manager. This is a fantastic opportunity to join a busy,...  ...candidates with right to work only What You’ll Be Doing Leading the business’ US Regulatory Affairs operations,... 
    Senior
    Medical device
    Permanent employment
    Full time

    Connect Life Science

    Minneapolis, MN
    1 day ago
  •  ...Senior Software Business Analyst Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Software Business...  ..., and a deep understanding of regulatory and compliance requirements...  ...at least 2 years in a senior or lead role. Proven experience in the... 
    Senior
    Medical device
    Contract work

    Pharmavise

    Maple Grove, MN
    4 days ago
  • $160k - $180k

    Senior Manager of Quality and Regulatory Plymouth, MN55441 Posted: 07/09/2026 Employment...  ...0,000 + Bonus Industry: Medical Device and Healthcare...  ...based execution of clinical affairs processes, as well as...  ...assurance compliance. Leading efforts in support of QMS... 
    Senior
    Medical device
    Permanent employment
    Contract work
    Local area
    Worldwide
    Flexible hours

    Dahl Consulting

    Plymouth, MN
    4 days ago
  •  ...513809Reference25-04468 Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including...  ...successful approval and launch of innovative medical devices. Responsibilities: Prepare, review, and... 
    Senior
    Medical device

    Katalyst Healthcares & Life Sciences

    Minneapolis, MN
    1 day ago
  • Job-ID32834640Reference26-01421Summary:We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.Roles & Responsibilities:10+ years of Quality Engineering experience in medical device manufacturing.Strong... 
    Senior
    Medical device
    Contract work

    Katalyst Healthcares & Life Sciences

    Brooklyn Park, MN
    2 days ago
  • $55k - $75k

     ...HCM is looking for a detail-oriented Quality Inspector to ensure precision-manufactured components meet quality standards in the medical device sector. In this role, you will carry out both in-process and final inspections using calibrated equipment and maintain... 
    Senior
    Medical device

    Cypress HCM

    Osseo, MN
    3 days ago
  • $95k - $126k

     ...Minnesota City: Maple Grove SummaryThe Lead Engineer, Design Quality supports the quality...  ...of products and projects in the medical device, aerospace & defense, industrial, and smart...  ...’ technical staff regarding customer/regulatory audits Provide guidance and support to... 
    Senior
    Medical device
    Temporary work
    Work at office
    Worldwide
    Shift work

    Celestica

    Maple Grove, MN
    2 days ago
  • $203k - $253k

     ...Sr. Director, Strategic Regulatory Affairs and UDI The Senior Director, Strategic Regulatory...  ...systems, unique device identification (UDI), regulatory...  ...disciplines. The position leads a global organization through...  ..., Quality, Compliance, Medical Device Operations, Healthcare... 
    Senior
    Medical device
    Temporary work
    Work at office
    Remote work
    Flexible hours

    Teleflex

    Maple Grove, MN
    4 days ago
  • $92k - $138k

     ...first — developing innovative medical technologies that improve...  ....  In collaboration with leading clinicians, researchers, and...  ...are looking for a passionate Senior Regulatory Affairs Specialist who has direct...  ...labeling and changes to existing devices and documentation. Support... 
    Senior
    Medical device
    Full time
    H1b
    Local area
    Immediate start
    Worldwide
    Flexible hours

    Medtronic

    Minneapolis, MN
    4 days ago
  • Boston Scientific is seeking a Senior Design Quality Engineer to support high-visibility quality initiatives and sustainment activities...  ...and risk management are robust and compliant. The candidate will lead quality processes, mentor staff, and drive improvements in... 
    Senior
    Medical device

    Boston Scientific

    Osseo, MN
    5 days ago
  •  ...Design Quality Engineer III to support high‑visibility design quality activities, ensuring safety, quality and compliance for launched devices, including SEISMIQ console sustainment at Arden Hills and Carlsbad. This hybrid role, based at the Arbor Lakes Campus in Maple... 
    Senior
    Medical device
    3 days per week

    B Capital

    Osseo, MN
    5 days ago
  • $113.03k - $165.77k

     ...safety and quality requirements. Develops US and International regulatory strategies for product submissions, identifying needs for...  ...field. Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD... 
    Senior
    Medical device
    Immediate start

    Integer Holdings

    Minneapolis, MN
    1 day ago
  • $132.9k - $199.4k

     ...strategic, and driven Senior Global Product Manager...  ...peripheral intervention leading both global commercial...  ...with R&D, Clinical, Regulatory, and Commercial teams...  ...Regulatory, Clinical Affairs, Sales, Supply Chain,...  ...intervention or a related medical device space Experience in... 
    Senior
    Medical device
    Temporary work
    Work at office
    Remote work
    Flexible hours

    Teleflex

    Maple Grove, MN
    2 days ago
  •  ...days per week at the Arbor Lakes Campus in Maple Grove, MN, with consideration for Arden Hills. You will ensure safety, quality, and regulatory compliance for launched products while driving design controls and continuous improvement. #J-18808-Ljbffr Boston Scientific
    Senior
    Medical device
    3 days per week

    Boston Scientific

    Osseo, MN
    5 days ago
  • Boston Scientific is hiring a Senior Design Quality Engineer for Bolt Integration at the Arbor Lakes Campus in Maple Grove, MN. The role...  ...requires collaboration across R&D, manufacturing, supplier and regulatory functions to protect design intent and ensure safety and... 
    Senior
    Medical device
    Relocation package
    3 days per week

    Boston Scientific Gruppe

    Osseo, MN
    5 days ago
  • $125.8k

     ...your ambitions. About the role: The Senior Manager, Commercial AI & Digital Strategy is responsible for defining and leading a new strategic capability within...  ...leadership.   Preferred qualifications: ~ Medical device, health care or life sciences experience.... 
    Senior
    Medical device
    Hourly pay
    Work at office
    Local area
    Relocation
    Relocation package
    Shift work
    3 days per week

    Boston Scientific

    Maple Grove, MN
    2 days ago
  • $137.7k

     ...About the Role Reporting to the Senior Director of Business...  ...time. Key Responsibilities Lead assessments of new markets /...  ...Marketing, Research, R&D, Clinical, Regulatory, and/or other functions as appropriate...  ...in the healthcare domain (medical device experience preferred).... 
    Senior
    Medical device
    Hourly pay
    Relocation package
    Shift work
    3 days per week

    Boston Scientific

    Osseo, MN
    5 days ago
  •  ...your ambitions. About the role: The Senior Manufacturing Engineer will lead continuous improvement initiatives...  ...-site teams (Production, Quality, Regulatory, R&D, Process Development, Supply...  ...experience Experience in the medical device industry Experience with troubleshooting... 
    Senior
    Medical device
    Hourly pay
    Full time
    Work at office
    Shift work

    Boston Scientific Corporation

    Maple Grove, MN
    2 days ago

Do you want to receive more vacancies?

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