Senior Regulatory Affairs Leader — Remote Medical Devices
USA SOLVENTUM US LLC
- Remote job
Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product approvals across global markets. You will guide a team, coordinate with product development, clinical, and quality assurance to ensure regulatory compliance throughout the lifecycle of Restorative Healing Technologies. The role requires extensive experience in medical device regulatory submissions (510(k), EU MDR) and audits (ISO 13485, MDSAP), with remote/work-from-home flexibility #J-18808-Ljbffr USA SOLVENTUM US 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 workSeniorMedical device- Solventum, a health care innovator, seeks a Senior Regulatory Affairs Specialist to lead a team supporting Restorative Healing Technologies and... ...and coordinating with internal and contract partners to meet milestones. Remote US work available. #J-18808-Ljbffr SOLVENTUMRemote jobSeniorMedical deviceContract work
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for the... ...Restorative Healing Technologies portfolio. Remote work is available in the United... ...record in regulatory affairs within medical devices, plus experience with ISO 13485,...Remote jobSeniorMedical device
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for Restorative Healing Technologies on a global scale. This remote US role emphasizes building regulatory strategy, coordinating cross-functional teams, and ensuring compliance from...Remote workSeniorMedical deviceContract work
$109k - $174.8k
...merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...United States of America, Remote (US) Job Description: About... ...for the best talent for a Senior Regulatory Affairs Program... ...modified and currently marketed medical devices. He/she guides conformance...Remote workSeniorMedical deviceFull timeLocal areaImmediate start- MiniMed, a global leader in diabetes care, seeks a Principal Regulatory Affairs Specialist to guide medical devices and software through US FDA, EU MDR, and other global pathways.... ..., EU, and international teams. This 100% remote role offers collaboration across functions...Remote jobSeniorMedical device
- ...requirements. The role combines on-site leadership at our Chaska, MN headquarters with remote work flexibility, reporting to the VP of Operations, QARA, and Customer Service. A strong background in medical device quality is essential. #J-18808-Ljbffr IMRIS Imaging, Inc DBA IMRISRemote workSeniorMedical device
- OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory... ...SaMD/SiMD and electromechanical devices. The role requires... ...compliance with ISO, GMP, and medical device standards. The position offers flexible remote or hybrid on-site work in Madison...Remote jobSeniorMedical deviceFlexible hours
- ...Experience Research or Human Factors Manager with an independent book of business to join our Human Factors team, focusing on medical device or healthcare UX. The role emphasizes business development alongside high-level research, mentoring, and strategic growth. You...Remote jobSeniorMedical device
- ...technology development, the full-time Senior Regulatory Affairs Specialist will prepare and manage... ...collaborating with cross-functional teams in a remote setting, preferably from the East... ...+ years of regulatory experience in medical devices or pharmaceuticals Strong...Remote workSeniorMedical deviceFull time
- ...Leading regulatory support for product development teams, the full-time Senior Regulatory Specialist will prepare... ...global regulations in a remote setting. Key... ...regulatory specialist in the medical device or pharmaceutical... ...regulations Regulatory Affairs Certification (RAC)...Remote workSeniorMedical deviceFull time
- Werfen in Bedford, MA seeks a Regulatory Affairs professional to lead pre-market activities for FDA, Health Canada and EU submissions, ensuring... ...successful launches. Candidates bring at least 8 years of medical device regulation experience with strong written and verbal...SeniorMedical device
- W. L. Gore & Associates, Inc. is seeking a Regulatory Affairs Leader for the Aortic Business Group. This remote role develops global regulatory strategies and directs... ...obtain and maintain marketing approvals for medical devices, including PMA products. You will lead...Remote jobMedical device
- Johnson & Johnson is seeking a Regulatory Affairs Manager for Digital Health to lead FDA submissions, advise on global regulatory requirements... ...cybersecurity, SiMD/SaMD, and AI/ML in a complex medical device ecosystem, with an emphasis on ensuring compliant, timely product...Remote jobMedical device
- ...0Reference26-00910Remote50% Remote Job Description Key Responsibilities... ...for FDA inspections, regulatory meetings, and compliance... ...Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering,... ...industries such as Pharma, Medical Devices, Biotechnology, or...Remote workSeniorMedical device
- A leading medical device company is seeking a Medical Writer Specialist to prepare regulatory documents and conduct scientific writing. This role demands a Ph.D/Pharm D or... ...position is based in Raynham, MA, with options for remote work for experienced professionals. #J-18808...Remote jobSeniorMedical deviceWork at office
- ...one of the largest global medical technology companies in the... ...an outstanding chance for a Senior Regulatory Affairs Specialist to join a world-... ...vital for marketing medical devices internationally. This role... ...flexibility and work-life balance. Remote or field-based positions...Remote workSeniorMedical deviceFull timeWork at officeWorldwide
- ...pharmaceutical, biotech, and medical device organizations to address complex regulatory and operational... ...safety, and regulatory affairs, supporting clients in... ...experienced Consultant or Senior Consultant with a strong... ...is preferred Fully remote role Occasional client...Remote workSeniorMedical deviceFull time
$100.32k - $125.4k
...- Hybrid (3 days onsite) Senior Specialist, Regulatory AffairsAdvanced Bionics is... ...Senior Specialist, Regulatory Affairs to develop and execute... ...experience with Class III medical devices, PMA submissions, and global... ...required to support any remote/hybrid employee functionality...Remote workSeniorMedical deviceTemporary workWork at officeFlexible hours- ...the largest global medical technology... ...implement comprehensive regulatory strategies for new... ...junior regulatory affairs professionals, fostering... ...the medical device industry, with at... ...in a leadership or senior role.Demonstrated... ...work-life balance. Remote or field-based positions...Remote workSeniorMedical deviceFull timeWork at office
- ...Locations Remote Regulatory Affairs Full-Time Kennesaw 1655 Roberts Blvd NW Kennesaw, GA... ...Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple... ..., . Position Overview: The Senior Director Regulatory Affairs, Product...Remote workSeniorMedical deviceFull timeWorldwide
- Kite Pharma is seeking a Senior Regulatory Affairs Leader to guide global regulatory strategies for oncology programs in Santa Monica and potential relocation considerations. You will lead cross-functional teams, drive submissions to FDA/EMA, and ensure compliance across...Remote jobSeniorRelocation
- ...re actively seeking qualified candidates for a Senior Regulatory Affairs Specialist opportunity supporting medical device regulatory submissions and compliance. Key Responsibilities... ...Details Location: Jacksonville, FL preferred; remote candidates may be considered based on...Remote workSeniorMedical deviceFull timeContract work
- Emmes is seeking a Manager, Regulatory Affairs to lead regulatory strategy for multiple clinical development programs. The role combines advisory... ...INDs, and approval pathways. Based in the United States with remote work options, you will manage a team of Regulatory Affairs...Remote jobSenior
$125k - $201.25k
...Job Function: Regulatory Affairs Group Job Sub Function... ...Posting Locations: Remote (US) Santa Clara... ...the best talent for a Senior Regulatory Affairs Program... ...of electromechanical devices with software enabled... ...affairs experience in medical devices including experience...Remote workSeniorMedical deviceFull timeLocal areaImmediate startFlexible hours- ...their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...United States of America, Remote (US) Job Description: About... ...for the best talent for a Senior Regulatory Affairs... ...modified and currently marketed medical devices. This includes the...Remote workSeniorMedical device
$140 per hour
...Job Title: Senior Teamcenter PLM Solution Architect & Discovery Lead Location: Remote within the United States, with approximately 40 hours of onsite discovery engagement... ...: We're partnering with a leading medical device company on a long-term PLM transformation...Remote workSeniorMedical deviceHourly payLong term contractFull timePart timeLocal area$100.32k - $125.4k
Valencia, CA - Hybrid Role Senior Specialist, International (China) Regulatory Affairs Advanced Bionics is seeking a Senior... ...activities for Class III medical devices, with a primary focus on China... ...connectivity is required to support any remote/hybrid employee functionality...Remote workSeniorMedical deviceTemporary workWork experience placementWork at officeLocal areaFlexible hours$141k - $261.8k
...GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and... ...are seeking an experienced Senior Quality Lead to join the Quality... ...discussions with Legal and Regulatory Affairs.PDQ Goals and Initiatives:... ...is preferred, however, a remote option is a possibility.)Relocation...Remote workSeniorMedical deviceLocal areaRelocation package- ...From clinical trials to regulatory, consulting, and... ...We are seeking a Senior Regulatory Affairs Associate, Regulatory... ...to join our team in a remote capacity. As a Senior... ...drug, biologic, and device development processes... ...Pharmaceuticals and Medical Devices Agency (PMDA)...Remote workSeniorMedical deviceFull timeWork experience placementWork at officeWorldwideFlexible hours
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