Senior Regulatory Affairs Strategist for Medical Devices
Bracco Medical Technologies
Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and execute regulatory strategies for medical device products throughout their lifecycle. You will provide hands-on regulatory support for submissions, labeling, and ongoing compliance across global markets. The role requires leading cross-functional teams, coordinating FDA interactions, audits, and regulatory communications while maintaining complete regulatory files and documentation. #J-18808-Ljbffr Bracco Medical Technologies
- Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist in the United States to develop and execute regulatory strategies for medical device products, submissions, and lifecycle changes. The role provides hands-on regulatory support for new product...SeniorMedical device
- Elucent Medical Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies and submissions for medical devices. This role focuses on FDA 510(k) pathways, ensuring compliance throughout the product lifecycle. With a minimum of 7 years of experience...SeniorMedical device
- Elucent Medical, Inc. is hiring a Principal Regulatory Affairs Specialist in Eden Prairie, MN. This role requires advanced knowledge of U.S. FDA regulations... ...strategies, submissions, and compliance for medical devices. The position emphasizes hands-on execution and collaboration...SeniorMedical device
- MTS Systems Corporation is seeking a Global Trade Compliance Specialist Senior to support export/import operations and ensure world‑wide regulatory compliance. You will work with Legal, Supply Chain, Sales, Engineering, and Logistics to maintain a robust trade compliance...Senior
$230k - $250k
...makes everything possible. The Senior Director, Quality Operations... ...site execution, ensures regulatory compliance, and drives a strong... ...Chain, and Regulatory Affairs.This position reports to the... ...with in‑vitro diagnostics or medical device industry, with direct accountability...SeniorMedical deviceFull timeLocal area- AMETEK, Inc. seeks a Quality Manager for Advanced Medical Components to lead QMS deployment across sites, ensure compliant documentation... ...analysis. The role requires extensive experience in medical device quality, auditing, risk management per ISO 14971, and proficiency...SeniorMedical device
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates with... ..., Declarations of Conformity, and Medical Device Licenses—for various global markets.Support...SeniorMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$160k - $180k
Senior Manager of Quality and Regulatory Plymouth, MN55441 Posted: 07/09/2026 Employment Type: Permanent... ...,000 - $180,000 + Bonus Industry: Medical Device and Healthcare Technology ---... ...risk-based execution of clinical affairs processes, as well as product verification...SeniorMedical devicePermanent employmentContract workLocal areaWorldwideFlexible hours- Hims & Hers is seeking a Senior Product Development Engineer to join our medical device team. You will design and validate consumer medical devices and their packaging... .... You will collaborate across Quality, Regulatory, Operations, and Supply Chain to align on packaging...SeniorMedical device
$109k - $174.8k
...employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category... ...10K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA. Generates...SeniorMedical deviceFull timeTemporary workLocal areaWorldwide$85k - $167.3k
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need...SeniorWork experience placementInterim roleRemote workFlexible hours- ...design techniques using Creo Parametric. The ideal candidate will bring over 10 years of experience, particularly in the hearing or medical device industry, and possess a strong background in GD&T and injection molded processes. A competitive salary and comprehensive...SeniorMedical device
$106k - $130k
...AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent... ...contribute professionally and personally. Position Summary The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and...SeniorMedical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- ...mentor peers to elevate engineering practices. The role emphasizes hands‑on design, validation, and continuous improvement, with a strong focus on delivering best‑in‑class products in a fast‑moving medical device environment. #J-18808-Ljbffr Starkey Hearing TechnologiesSeniorMedical device
$105k - $135k
A leading engineering firm in Eden Prairie is seeking a Senior Engineer to lead product design and development for innovative hearing... ...in product development, particularly in the hearing or medical device industry. The target salary ranges from $105,000 to $135,000 annually...SeniorMedical device$85k - $95k
A leading medical device organization in Minnetonka is seeking a Senior Accountant to support financial operations and reporting. This role collaborates with the Financial Controller on compliance and strategic analysis. The ideal candidate will hold a Bachelor’s degree...SeniorMedical device- ...should have at least 6 years in project management and a Bachelor’s degree. The role may require up to 20% travel. Strong interdisciplinary collaboration and communication skills are essential, along with a history in medical device manufacturing. #J-18808-Ljbffr SolventumSeniorMedical deviceRemote job
- DriSteem is seeking a Senior Logistics Analyst to develop and optimize our transportation network for both domestic and international shipments. This onsite role in Eden Prairie, MN focuses on improving service-to-cost ratios and managing carrier relationships across regions...Senior
- Carlson Family Office in Minnetonka seeks a senior tax professional to own end-to-end compliance and planning for a multi-generational family. You will work with internal and outside advisors to deliver high-trust tax outcomes. The role emphasizes technical depth, independence...SeniorWork at office
- ...particularly utilizing Creo Parametric. Candidates must have a solid background in mechanical design, ideally with experience in the medical device sector. The ideal candidate will demonstrate advanced skills in CAD software, strong communication abilities, and a commitment...SeniorMedical device
$131k - $143k
Why Join Bracco Medical Technologies?We care as much about our employees as we do our patients... .......every day!About the RoleThe Principal Regulatory Affairs Specialist develops and executes regulatory strategies for medical device products, submissions, and lifecycle...Medical device- ...Why Join Bracco Medical Technologies? We care as much about our employees as we do... ...systems integration for Class II Medical Devices including SDLC (Software Development Lifecycle... ..., System Test, Quality Assurance and Regulatory Affairs to coordinate activities, produce...SeniorMedical deviceFull time
$140k - $185k
...talents. POSITION SUMMARY: The Senior Manager, Manufacturing Operations leads... ...in a production environment in the medical device or pharmaceutical industry which incorporated... ...cGMP, quality systems, ISO standards, regulatory expectations, audit readiness,...SeniorMedical deviceWork at officeShift work$150k - $175k
...difference in people's lives. Our medical devices, software and related... ...are consistent with legal and regulatory standards and company... ...contribution, overseeing key Clinical Affairs functions and supporting... ...provide regular updates to senior leadership.Manage clinical activities...SeniorMedical deviceMinimum wageOngoing contractFull timeContract workTemporary workWork at officeLocal areaRemote workWorldwideNight shift3 days per week$45 - $60 per hour
...1 CFR Part 11 and Part 820, and internal protocols to ensure regulatory compliance and robust quality systems.Plan and execute Design... ...Manufacturing Practices (GMP) in a regulated setting.Experience in medical device manufacturing or similarly regulated industries.Demonstrated...SeniorMedical devicePermanent employmentTemporary work$65k - $95k
Piper Companies is looking for a Senior Equipment Systems & Vendor Associate to join a biotechnology company located in Eden Prairie... ...in a GMP‑regulated pharmaceutical, biotechnology, or medical device environment preferred Experience with Blue Mountain RAM (BMRAM...SeniorMedical device$65k - $85k
Senior Equipment Systems & Vendor Associate page is loaded## Senior... ...external liver assist device for acute liver failure (miroliver... ...compliant with internal and regulatory expectations. The Senior Equipment... ...pharma, biotech, or medical device environment with a H.S...SeniorMedical deviceWork at officeWorldwide$32 - $36 per hour
...Job Description Job Description A medical device client is looking to hire a full time, Senior Quality Technician onsite in Eden Prairie, Minnesota. This Monday-Friday, onsite quality professional will need to perform material and product assessment testing in support...SeniorMedical deviceFull timeMonday to Friday- Bracco Medical Technologies is seeking an experienced General Counsel to serve as the primary legal advisor... ..., compliance matters, complex contracting, and regulatory affairs for a fast-paced, highly regulated medical device business, collaborating with cross-functional...Medical device
- Senior Design Assurance EngineerThe Sr. Design Assurance Engineer supports new product... ...products meet design, quality, regulatory, and safety requirements. The role focuses... ...compliance. A key responsibility is supporting medical device software development in compliance with...SeniorMedical device
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