Global Regulatory Affairs Specialist - Medical Devices
AtriCure
AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. You will submit 510(k), PMA supplements, and global filings, while guiding regulatory strategy on new products and post-market changes. You’ll collaborate with cross-functional partners to ensure timely approvals and compliance. The role requires regulatory expertise for medical devices, strong technical writing, and ability to travel #J-18808-Ljbffr
- ...Laborie is seeking a Regulatory Affairs Specialist to join our team in a hybrid role based out of Minnetonka, MN or Portsmouth, NH. You will support global product registration, approvals, and lifecycle management across major markets including the US, Canada, Europe,...Medical device
- ...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
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.Support cross-functional...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Electrophysiology business in Plymouth, Minnesota, seeks a regulatory affairs specialist to prepare documentation for regulatory submissions in... ...comprehensive career development and competitive benefits, including medical coverage and retirement plans. #J-18808-Ljbffr...Medical device
- ...Who We’re Looking For Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist to join our team in hybrid... ...Affairs Specialist will support global product registration,... ...Regulatory Affairs in the medical device industry 1-3 years\' experience...Medical deviceWorldwideFlexible hours
$106k - $130k
...Synergy Ablation System is the first medical device to receive FDA approval for the... ...personally. POSITION SUMMARY The Senior Regulatory Affairs Specialist originates appropriate documents to... ...personnel on assessing and documenting the global impact of product change on product...Medical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- 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
- ...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... ...and ongoing compliance across global markets. The role requires leading...Medical device
$120k - $180k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...extraordinary. The Principal Regulatory Affairs Specialist will play a key role in... ...regulatory life cycle of medical devices and strong working...Medical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$92k - $138k
...start here. Medtronic is a global leader in healthcare technology... ...— developing innovative medical technologies that improve... ...looking for a passionate Senior Regulatory Affairs Specialist who has direct experience... ...and changes to existing devices and documentation. Support...Medical deviceFull timeH1bLocal areaImmediate startWorldwideFlexible hours$165.55k - $260.15k
...essential in everyday technology devices from smartphones to electric... ...processes across Spectrum’s global Healthcare manufacturing... ...meet critical-to-quality (CTQ), regulatory, and customer requirements.Operational... ...experience, ideally in the medical device manufacturing industry...Medical deviceFlexible hours$131k - $143k
...Why Join Bracco Medical Technologies? We care as much about our... ...the Role The Principal Regulatory Affairs Specialist develops and executes regulatory... ...strategies for medical device products, submissions, and... ...changes to existing devices, global registrations, audits, labeling...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
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity... ...strategies, prepare global regulatory submissions and... ...positive relationships with device reviewers through oral and... ...related discipline within the medical device industry, including...Medical deviceHourly payWork at officeLocal areaShift work3 days per week
- ...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
- The Regulatory Affairs Specialist will play a key role in supporting regulatory strategy and compliance... ...product lifecycle. Reporting to the Global Product Director, this individual... ...regulatory strategies supporting Class II medical devices throughout the product lifecycle....Medical deviceInternshipWork at office
- Job Title: Regulatory Affairs Specialist II Location: Minneapolis, MN 55401, US (Primary) Education:... ...Responsibilities Evaluates potential global regulatory pathways for US, EU, and... ...3-5 years' experience in regulated medical device industry highly preferred. Knowledge...Medical deviceFull timeWork at office
- ...the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory... ...Affairs Department supporting global post-market compliance activities. The... ...Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences...Medical deviceWeekly payTemporary workFlexible hours
$78k - $156k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...manufacturing, supply chain, clinical, regulatory, quality and marketing.• Implements policies...Medical deviceFor contractorsWorldwideShift work$113.3k - $226.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people... ...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...closely with R&D, Clinical, Medical Affairs, Regulatory, Health Economics, and regional commercial...Medical deviceWorldwideShift work$74.4k - $111.6k
...Regulatory Affairs Specialist Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate... ...developing innovative medical technologies that improve... ...and changes to existing devices and documentation. Provide...Medical deviceH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$120.49k - $192.78k
...Principal Regulatory Affairs Specialist Join RespirTech's team in Plymouth, MN as... ...you will develop and execute global regulatory strategies for... ...innovative airway clearance therapy devices, enhancing product... ...experience within FDA regulated Medical Device environments, with a...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$85k - $104k
...Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment... ...FUNCTIONS OF THE POSITION: Support global regulatory pre-market applications for... ...Change Control) Work with Regulatory Affairs staff, engineers and technical experts...Medical deviceContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote workWorldwide$129.5k - $203.5k
...that are essential in everyday technology devices from smartphones to electric vehicles, or... ...like Spectrum and Liveo, we advance global health through innovation.We are hiring a... ...skillsPreferred ExperienceCardiovascular or medical device market experienceGlobal / cross-cultural...Medical deviceRemote work- ...leading contract research organization is looking for a Senior Regulatory Affairs Manager in Minneapolis, MN. The role involves managing... ...a Master's degree and have 7–10 years of experience in the medical device industry, with a strong track record in obtaining 510(k) approvals...Medical deviceContract work
- Medtronic plc is seeking a Senior Regulatory Affairs Specialist to lead worldwide product registrations... ...to the FDA, EU MDR, and other global agencies, and collaborating with cross... ...global regulatory strategy for high-risk medical devices, leveraging your experience to...Medical deviceWorldwide
- ...verification/validation within a regulated medical device environment. Roles &... ...requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)... ..., military) ~ Experience working with global, cross-functional teams ~ Bachelor's...Medical deviceFull time
$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...Medical deviceImmediate start$167k - $315k
...Teleflex is a global provider of medical technologies, driven by our purpose to improve the health and quality of people’s lives. Through our... ...Interventional business unit at Teleflex develops innovative medical devices used to diagnose and treat coronary and peripheral...Medical deviceTemporary workFlexible hours$135k - $145k
...- innovating at the speed of life.As a global leader in clinical diagnostics, Beckman... ...partnering constructively with Quality, Regulatory, and Operations stakeholders.The... ...and technology transfer projects in the Medical Device or Diagnostics regulatory environment,...Medical deviceFull time
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