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.
$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....SeniorMedical deviceFull timeTemporary workLocal areaWorldwide$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...SeniorMedical deviceTemporary workLocal areaWorldwide- 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
- ...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...SeniorMedical deviceHourly payFixed term contractWork at officeLocal areaShift work3 days per week
- 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...SeniorMedical device
- ...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...SeniorMedical deviceWork at officeLocal area3 days per week
- 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...SeniorMedical device
$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....SeniorMedical deviceWork experience placementShift work- 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...SeniorMedical deviceWork at officeRelocation
- 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...SeniorMedical device
- 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 deviceWorldwide
$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...SeniorMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- 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,...SeniorMedical devicePermanent employmentFull time
- ...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...SeniorMedical deviceContract work
$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...SeniorMedical devicePermanent employmentContract workLocal areaWorldwideFlexible hours- ...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...SeniorMedical device
- 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...SeniorMedical deviceContract work
$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...SeniorMedical device$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...SeniorMedical deviceTemporary workWork at officeWorldwideShift work$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...SeniorMedical deviceTemporary workWork at officeRemote workFlexible hours$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...SeniorMedical deviceFull timeH1bLocal areaImmediate startWorldwideFlexible hours- 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...SeniorMedical device
- ...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...SeniorMedical device3 days per week
$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...SeniorMedical deviceImmediate start$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...SeniorMedical deviceTemporary workWork at officeRemote workFlexible hours- ...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 ScientificSeniorMedical device3 days per week
- 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...SeniorMedical deviceRelocation package3 days per week
$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....SeniorMedical deviceHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$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)....SeniorMedical deviceHourly payRelocation packageShift work3 days per week- ...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...SeniorMedical deviceHourly payFull timeWork at officeShift work
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