Global Regulatory Affairs Lead, Medical Devices
AtriCure
AtriCure, Inc. in Minnesota is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for US and international markets. You will prepare 510(k) submissions, PMA supplements, and global change documents, serving as regulatory lead on product development projects and post-market modifications to sustain approvals. This role requires collaboration with cross-functional teams, strong technical writing, and frequent interaction with FDA, EU Notified Bodies, Health Canada, and #J-18808-Ljbffr AtriCure
- 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. seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory documents (510(k), PMA, EU/Canada/Japan) to... ...other agencies. Requirements: Bachelor’s degree, 4+ years in medical device regulatory affairs, strong writing and communication skills...Medical deviceWorldwide
- EPM Scientific seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategy and submissions for a portfolio of dental drug and medical device products. You will steer regulatory activities on cross-functional teams, driving registrations, labeling...Medical deviceRemote jobWorldwide
$109k - $174.8k
...merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...currently seeking a Sr Program Lead, Regulatory Affairs to join... ...processes to assure timely global commercialization of... ...EU Technical Document for medical devices for commercialization in the...Medical deviceFull timeTemporary workLocal areaWorldwide- Laborie Medical Technologies is seeking a Regulatory Affairs Specialist for a hybrid role in Minnetonka, MN. You will support global product registrations and lifecycle maintenance for the US,... ...engineering and 1-3 years’ medical device regulatory experience are required...Medical device
- 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
- 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
- Katalyst CRO is seeking a highly skilled Medical Device Labeling Engineer based in Minneapolis, Minnesota. This position involves developing... ..., ensuring compliance with FDA and EU regulations, and leading labeling implementation activities. The ideal candidate should...Medical device
- A global technology group is looking for a Project Manager to lead the development of cost models, track project performance, and translate user needs into requirements... ...field, with over 3 years of experience in the Medical Device industry and 2 years in a leadership role....Medical deviceFull time
- AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. This role will prepare submissions and support regulatory strategies for new product development and post-market changes. You...Medical device
$109k - $174.8k
...Sr Program Lead, Regulatory Affairs Johnson & Johnson MedTech is currently seeking a Sr Program... ...strategies and processes to assure timely global commercialization of products in... ...submissions and EU Technical Document for medical devices for commercialization in the USA....Medical deviceTemporary workLocal areaWorldwide- A global technology group is seeking a Principal Research and Development Engineer for... ...have at least 12 years of experience in medical device design and development, and possess a Bachelor... ...preferred. Key responsibilities include leading product improvements and technical...Medical device
$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- Solventum, a new healthcare company, seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Dental Solutions portfolio across global markets, including the United States, Canada, and the EU. You will guide regulatory strategy, coordinate...Remote job
$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- 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...Medical device
$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- ...Electrophysiology business in Plymouth, Minnesota, seeks a regulatory affairs specialist to prepare documentation for regulatory submissions... ...career development and competitive benefits, including medical coverage and retirement plans. #J-18808-Ljbffr AbbottMedical device
$142.21k - $213.32k
...This role is responsible for leading the global upstream marketing team tasked with... ...closely with R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Medical Affairs, Operations, and other... ...commercial roles within medical devices or healthcare. ~ Experience supporting...Medical deviceImmediate startWorldwideFlexible 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- ...MN is seeking an External Manufacturing Leader to drive end-to-end management of a global third-party manufacturing network in a highly regulated medical device environment. You will lead CMOs, strengthen infrastructure, and ensure supply continuity, quality, cost and...Medical device
$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- ...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
$78k - $156k
...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... ...manufacturing, supply chain, clinical, regulatory, quality and marketing.•...Medical deviceFor contractorsWorldwideShift work$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- Philips seeks an External Manufacturing Leader to drive execution across a global third-party manufacturing network in a highly regulated medical device environment. You will strengthen infrastructure, elevate operational rigor, and build scalable processes across a global...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
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