Senior Regulatory Affairs Lead - Med Device (Remote)
VB Spine, LLC
- Remote job
VB Spine, LLC is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for spinal products. You’ll collaborate with cross-functional teams from early development through market approvals, drafting 510(k)s and technical documentation for US, EU, and other markets. You will communicate with FDA and other Health Authorities, guide post‑market submissions, and help ensure compliance across QA, engineering, and manufacturing. Remote work options with travel are available. #J-18808-Ljbffr VB Spine, LLC
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workSenior- Jobtailor is seeking an experienced Regulatory Affairs professional in the United States to drive regulatory strategy for new medical device products. You will collaborate across engineering... ...skills. Advanced degrees are a plus; remote work options may vary. #J-18808-Ljbffr...Remote workSenior
- BrioHealth Solutions is seeking a Senior Regulatory Affairs Specialist to support the BrioVAD LVAS. This role partners with clinical, R&D, quality... ...help navigate EU MDR and CE marking efforts for class III devices. Candidates should bring strong technical writing and...Senior
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotic instruments and accessories. You will partner with engineering and clinical teams, develop submission-ready documentation, and guide global regulatory...Remote jobSenior
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization... ...environment, and strong communication skills. This position is remote and requires some travel. Competitive salary and benefits...Remote jobSenior
- Calyxo, Inc. in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities from concept to commercialization of category-defining medical devices. You will own U.S. and international submissions and partner with R&D, Operations, Quality...Senior
- Advita Ortho in the US (Remote) seeks a Sr Manager, Regulatory Affairs to provide strategic leadership for the postmarket regulatory team, directing regulatory... ...management. The role requires 10+ years in medical device regulatory affairs, US/EU experience, RAC preferred,...Remote jobSenior
$111k - $149k
Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to provide regulatory expertise for global strategies, with focus on device and combination products. You will collaborate with cross-functional teams, lead regulatory submissions...Remote jobSenior- ...in Lake Zurich, IL seeks a Senior Manager of Regulatory Affairs to drive regulatory... ...strategy for complex products, lead cross‑functional teams, and... ...in Lake Zurich with some remote work and offers an annual... ...plus years in regulatory, device/drug knowledge, and strong...Remote workSenior3 days per week
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Cincinnati... ...requires advanced knowledge of medical device regulations, strong communication, and up to 25% travel. Remote options may be considered case-by-case....Remote workSenior
- OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America,... ...for SaMD/SiMD and electromechanical devices. The role requires collaborating... ...standards. The position offers flexible remote or hybrid on-site work in Madison,...Remote jobSeniorFlexible hours
$169.5k - $248.6k
...About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global... ...of experience in regulatory affairs and/or drug developmentORBachelor... ...and relocation is provided, remote is not available for this...Remote workSeniorLocal areaRelocationFlexible hours- Providence Swedish is seeking a Senior Cardiac Device Technician to join the Heart and Vascular team in the Seattle area. You will perform interrogation... ...defibrillators, and implantable loop recorders, and manage remote transmissions under physician supervision in a busy...Remote workSenior
- ...A leading medical device company in Austin, TX seeks a Senior Regulatory Affairs Specialist to develop regulatory strategies and manage product submissions for innovative technologies within the orthopedic space. The candidate will work on medical devices that leverage...Senior
- Armiusa seeks a Senior Regulatory Affairs Consultant to develop regulatory strategies and ensure compliance for complex biologics and devices. Candidates should have extensive experience in regulatory affairs and a strong educational background in life sciences or engineering...Senior
$109k - $174.8k
...their merit. Job Function Regulatory Affairs Group Job Sub Function... ...States of America, Remote (US), Santa Clara, California... ...the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation... ...for specifications, device testing, risk management...Remote workSeniorLocal areaImmediate start- Abbott seeks a Principal Regulatory Affairs Specialist to provide regulatory leadership for endovascular medical devices in Santa Clara, CA or Temecula, CA. You will manage regulatory activities across U.S., EU, and other markets, supporting lifecycle management and global...Senior
- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through marketing... .... The role requires a minimum of 12 years in the medical device industry, with strong knowledge of regulatory standards and excellent...Senior
- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for the Vascular division,... ...Clara, CA or Temecula, CA. You will lead regulatory strategy, manage global submissions... ...The role requires 6-8 years in medical devices, experience with Class II/III devices,...Senior
- Viltis is seeking a Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA. The ideal candidate brings 7+ years of Medical Device Regulatory Affairs experience, with strong expertise in regulatory change assessments and U...Senior
- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations...Senior
- ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device products. You will analyze requirements, create regulatory... ...years in medical products, strong ability to lead regulatory arguments, and experience...Senior
- Abbott in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support worldwide submissions and regulatory strategies for medical devices. The role collaborates with product teams and manufacturing to prepare filings and maintain licenses, registrations,...SeniorWorldwide
- System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least 8 years of Regulatory Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on...Senior
- BioRobotics is seeking a Senior Regulatory Affairs Specialist at their California headquarters to oversee... ...surgery innovations. You'll lead cross-functional teams, develop regulatory... ...driving continuous improvement for medical devices. Join us to make a meaningful...Senior
- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist. The role involves supporting US and EU regulatory submissions while... ...adherence to regulations concerning medical devices. The ideal candidate should have over 7...SeniorWork at office
- Johnson & Johnson MedTech in Plymouth, MN seeks a Sr Program Lead, Regulatory Affairs to lead global regulatory strategies for medical devices and ensure timely commercialization in compliance with FDA and worldwide regulations. The role requires a Bachelor's degree in...SeniorWorldwide
- Innovative Health LLC in Scottsdale, AZ seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy, submissions, and compliance for high‑risk medical devices across the product lifecycle. You will prepare 510(k) submissions, PMAs, and related regulatory...Senior
- Jobtailor is seeking a Senior Regulatory Affairs professional in the medical device field to lead cross-functional regulatory initiatives and liaise with the FDA and other regulatory authorities. You will author SOPs, support submissions, and mentor teams on compliance...Senior
- Boston Scientific is seeking a Principal Regulatory Affairs Specialist to support regulatory compliance across post-market activities in the... ...have 5+ years in Regulatory Affairs/Quality for medical devices, knowledge of US and EU regulations, and strong technical writing...Senior
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