Global Regulatory Affairs Lead - Medical Devices
AtriCure
AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory documents (510(k), PMA, EU/Canada/Japan) to support worldwide marketing. You will serve on project teams for new products, ensure design control compliance, and liaise with FDA, EU Notified Bodies, Health Canada, and other agencies. Requirements: Bachelor’s degree, 4+ years in medical device regulatory affairs, strong writing and communication skills; travel 10–15%. #J-18808-Ljbffr
- ...Medtronic plc is seeking a Senior Regulatory Affairs Specialist to lead worldwide product registrations. The... ...to the FDA, EU MDR, and other global agencies, and collaborating with cross... ...regulatory strategy for high-risk medical devices, leveraging your experience to...Medical deviceWorldwide
- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain... ...submit 510(k), PMA supplements, and global filings, while guiding regulatory... ...role requires regulatory expertise for medical devices, strong technical writing, and ability...Medical device
$94k - $150k
Job TitleGSQ QMS Leader (Global)Job DescriptionGlobal Supplier Quality (GSQ... ...Supplier ecosystems within a regulated medical device environment. This role will lead cross-functional programs focused... .... Ensure consistent adoption, regulatory compliance, and sustained audit readiness...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Medtronic Regulatory Affairs Specialists lead worldwide product registrations with Geography Regulatory partners and global agencies. They provide expert advice, prepare submissions,... ...timely market access. The role requires medical device experience, FDA/EU submissions...Medical deviceWorldwide
$118k - $159k
IS Lead - Digital Solutions & Artificial IntelligenceTrelleborg... ...Solutions, Trelleborg Medical Solutions, and... ...with TMS objectives, regulatory expectations, and information... ...manufacturing, medical device, life sciences, or... ...advancement: Join a global company that loves to promote...Medical deviceWork at officeMonday to Friday3 days per week- ...organization. About the Role: ~ Lead the development and execution of comprehensive... ...tools. ~ Understanding of medical devices and industry regulations. ~... ...work hours as necessary to engage with global teams and supply partners. Why Laborie...Medical deviceContract workFlexible hours
- ...Boston Scientific seeks a Global Trade Compliance Director... ..., enforcement actions and regulatory engagements. Lead global customs, import and... ...legal counsel, Regulatory Affairs and external service providers... ...industries such as medical device, pharmaceutical, aerospace...Medical deviceWork at officeLocal areaRelocation3 days per week
$132.9k - $199.4k
...Sr. Global Product Manager, Strategic Marketing... ...peripheral intervention leading both global commercial... ...Partner with R&D, Clinical, Regulatory, and Commercial teams... ...Regulatory, Clinical Affairs, Sales, Supply Chain,... ...or a related medical device space Experience in...Medical deviceTemporary workWork at officeRemote workFlexible hours$165.55k - $260.15k
...in everyday technology devices from smartphones to electric... ...across Spectrum’s global Healthcare manufacturing... ...-to-quality (CTQ), regulatory, and customer requirements... ...inventory, productivity).Lead efforts in yield... ...experience, ideally in the medical device manufacturing industry...Medical deviceFlexible hours- ...Who We’re Looking For: Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist to join our team in... ...Affairs Specialist will support global product registration, approval,... ...Regulatory Affairs in the medical device industry 1-3 years' experience...Medical deviceWorldwideFlexible hours
$135k - $145k
...innovating at the speed of life.As a global leader in clinical... ...constructively with Quality, Regulatory, and Operations stakeholders... ...: 5+ years of experience in leading medium to large-scale technology... ...transfer projects in the Medical Device or Diagnostics regulatory...Medical deviceFull time$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs... ...Declarations of Conformity, and Medical Device Licenses—for various global markets.Support cross-functional... ...major changes to existing products.Lead global regulatory intelligence initiatives...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$171k - $273k
Job TitleDirector of Regulatory Affairs - RespirTech (Plymouth, MN)Job DescriptionDirector... ...of Regulatory Affairs will lead the Philips RespirTech... ...within the FDA regulated Medical Device industry, including 3+ years... ...experience/knowledge of global medical device regulations,...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$91.7k - $130k
Job Description:The Global Brand & Campaign Strategy Manager is... ...and drive demand. This role leads the development of differentiated... ...communications meet brand, regulatory, and quality expectations.... ...in healthcare, dental, or medical device industries preferred.Demonstrated...Medical deviceFull timeContract work$160k - $180k
...Manager of Quality and Regulatory Plymouth, MN5544... ...000 + Bonus Industry: Medical Device and Healthcare... ...design assurance and global regulatory compliance... ...execution of clinical affairs processes, as well as... ...assurance compliance. Leading efforts in support of...Medical devicePermanent employmentContract workLocal areaWorldwideFlexible hours$181k - $288k
...TitleDirector, Quality & Regulatory- Mergers &... ...continuity.Your Role:Lead end-to-end Quality & Regulatory... ...Partner with Regulatory Affairs, Legal, and external... ...monitoring, and support to global market organizations.... ...FDA regulated global medical device environments (Class...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...verification/validation within a regulated medical device environment.Roles & Responsibilities:... ...from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)... ...automotive, military)Experience working with global, cross-functional teamsBachelor's or Master...Medical device
$113.3k - $226.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps... ...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...with R&D, Clinical, Medical Affairs, Regulatory, Health Economics, and...Medical deviceWorldwideShift work$220k - $225k
...Trelleborg Medical Solutions is seeking a VP Global Quality and Regulatory, based from their Minneapolis MN headquarters... ...and support to lead the production team and... ...of life-saving devices. Growth and advancement... ...certification and/or Regulatory Affairs Certification (RAC)...Medical deviceFixed term contract$145.6k - $218.4k
...here. Medtronic is a global leader in... ...developing innovative medical technologies that... ...is responsible for leading and advancing Medtronic... ...with applicable regulatory requirements and... ...with the Medical Device Single Audit Program... ...Quality, Regulatory Affairs, Operations, R&D,...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within... ...possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and...Medical device
- ...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...Medical device
$129.5k - $203.5k
...essential in everyday technology devices from smartphones to electric... ...and Liveo, we advance global health through innovation.We are... ...Location: Remote What You’ll Do1. Lead Market StrategyDevelop and execute... ...ExperienceCardiovascular or medical device market experienceGlobal...Medical deviceRemote work$130k - $150k
...Principal Regulatory Affairs Project Manager - Medical Devices Global medical device manufacturer | Hybrid (3 days onsite) | Regulatory Affairs The role Our client... ...leader to own its highest-stakes programs. You'll lead cross-functional teams through global submissions,...Medical device$65 - $69 per hour
...Job Title: Regulatory Affairs Program Manager Location: Maple Grove, MN... ...Manager” to join one of our leading healthcare clients. Position... ...Program Manager will support the Global Regulatory Services team... ...programs across multiple medical device businesses. This role...Medical deviceHourly payLocal area$106k - $130k
...Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment... .... POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents... ...on assessing and documenting the global impact of product change on product registration...Medical deviceContract workTemporary workFor contractorsWork experience placementFor subcontractorWork at officeLocal areaWorldwide- ...The Regulatory Affairs Specialist will play a key role in supporting regulatory... .... Reporting to the Global Product Director, this individual... ...supporting Class II medical devices throughout the product lifecycle... ...registrations as needed. Lead EU MDR compliance activities...Medical deviceInternshipWork at office
- ...center of product quality and regulatory excellence. In this role, you... ...regulatory teams, helping ensure their devices meet the highest standards and are ready for global markets. If you love variety,... ...Profile: * 1+ year in medical devices OR engineering/startup...Medical device
$113.03k - $165.77k
...job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory... ...related field.Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA,...Medical deviceFull timeImmediate start$131k - $143k
...Why Join Bracco Medical Technologies?We care as much... ...the RoleThe Principal Regulatory Affairs Specialist develops and... ...for medical device products, submissions,... ...to existing devices, global registrations, audits,... ...practices.Experience leading or supporting FDA meetings...Medical device
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