Senior Regulatory Affairs Lead Remote (Medical Devices)
$115k - $185kLexington Medical, Inc.
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’s degree and extensive experience in medical device regulatory affairs. The position plays a crucial role in advancing the company's product pipeline and requires effective communication with cross-functional teams and regulatory authorities. Salary ranges from $115,000 to $185,000. #J-18808-Ljbffr
$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 workSeniorMedical device- 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 jobSeniorMedical device
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Cincinnati... ...role requires advanced knowledge of medical device regulations, strong communication, and up to 25% travel. Remote options may be considered case-by-case...Remote workSeniorMedical device
- 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 workSeniorMedical device
- 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 jobSeniorMedical device
- 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 jobSeniorMedical device
- ...merit.Job Function: Regulatory Affairs GroupJob Sub... ...States of America, Remote (US), Santa Clara,... ...best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation... ...specifications, device testing, risk management... ...experience within Medical Device is required...Remote workSeniorMedical deviceFull timeLocal areaImmediate start
- OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions... ...and electromechanical devices. The role requires collaborating... ...with ISO, GMP, and medical device standards. The position offers flexible remote or hybrid on-site work in...Remote jobSeniorMedical deviceFlexible hours
$109k - $174.8k
...merit. Job Function Regulatory Affairs Group Job Sub... ...States of America, Remote (US), Santa Clara,... ...best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation... ...specifications, device testing, risk... ...experience within Medical Device is required...Remote workSeniorMedical deviceLocal areaImmediate start- Innolitics LLC is a remote-first medical device consultancy hiring a Senior Regulatory Affairs Specialist to lead regulatory engagements for AI/ML-enabled SaMD. You will shape regulatory strategy, advise on FDA AI/ML framework, and drive Fast 510(k) sprints to completion...Remote jobSeniorMedical device
- ...Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and... ...interface for FDA inspections, regulatory meetings, and... ...with Quality, Regulatory Affairs, Manufacturing, Engineering... ...industries such as Pharma, Medical Devices, Biotechnology, or...Remote workSeniorMedical device
- ...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...SeniorMedical device
- 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...SeniorMedical device
- 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...SeniorMedical device
- 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...SeniorMedical device
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group, focusing on regulatory strategy for robotic instruments and accessories. You will collaborate with engineering and clinical teams to develop submissions, drive global...SeniorMedical device
- 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... ...commercialization. The role requires 6-8 years in medical devices, experience with Class II/III devices,...SeniorMedical device
- CooperVision is seeking a Principal Regulatory Affairs Specialist to provide expert regulatory support across UK&I, BeNeLux and Nordic regions... ...products from concept to launch and post-market. You will lead regulatory strategy, manage submissions, maintain regulatory...SeniorMedical device
- 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...SeniorMedical device
- Intuitive in Sunnyvale, CA seeks an experienced Regulatory Affairs professional to provide expert leadership in global submissions and compliance strategy. The role focuses on cross-functional coordination, technical documentation, and agency interactions to support product...SeniorMedical deviceWorldwide
- 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 difference...SeniorMedical device
- Abbott Laboratories seeks a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will lead regulatory submissions and guide cross-functional... ...FDA and EU pathways for SaMD and medical devices. The role requires 9+ years in...SeniorMedical device
- Verily Health is seeking a Regulatory Compliance Lead to develop and maintain fit-for-purpose regulatory frameworks across consumer,... ...ex-US expansion. Role requires 5+ years in regulatory affairs within medical devices or digital health; proficiency with Jira, GitHub, and...SeniorMedical device
- ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device products. You will analyze requirements, create regulatory strategies,... ...medical products, strong ability to lead regulatory arguments, and experience...SeniorMedical device
- Siemens Healthineers is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions, maintain lifecycle documentation, and ensure regulatory compliance across product development. You will collaborate with cross-functional teams, prepare technical files...SeniorMedical device
- BioTalent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment....SeniorMedical device
- 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,...SeniorMedical deviceWorldwide
- 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...SeniorMedical device
$150k - $175k
VitalConnect, located in California, is seeking a Regulatory Affairs professional responsible for ensuring compliance with medical device regulations. This includes writing and analyzing technical documents for regulatory submissions and maintaining regulatory files. The...SeniorMedical device- Bioventus LLC. is seeking a Senior Regulatory Affairs Specialist in Durham, NC. In this hybrid role, you will author and submit key regulatory applications... ...5% of the time. Join Bioventus and make a difference in helping patients lead active lives. #J-18808-Ljbffr Bioventus LLC.SeniorMedical device
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