Senior Regulatory Affairs Lead: HCT/P & Device-Combo
Dormont Manufacturing Co
Smith+Nephew is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions in Columbia, MD. This hybrid role requires a Bachelor’s degree in a scientific discipline and a minimum of 5 years’ hands-on experience in Regulatory Affairs, with expertise in FDA regulations. Responsibilities include leading strategy for human cells and tissues products, reviewing promotional materials, and ensuring compliance during FDA audits. The position also offers a competitive salary and comprehensive benefits including medical, dental, and generous PTO. #J-18808-Ljbffr Dormont Manufacturing Co
$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...SeniorRemote work- 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
- Biocartis is searching for a Senior Regulatory Affairs Specialist to develop regulatory strategies for compliance with IVDR and global standards. This remote position requires a Bachelor's degree and at least 5 years of experience in Regulatory Affairs, preferably with...SeniorRemote job
- EBR Systems, Inc. is hiring a Senior Clinical Research Associate in the United States to ensure study compliance and data integrity. The... ...of CRA experience on complex studies, preferably in the medical device sector, particularly with Class III cardiovascular rhythm...Senior
- Cresilon, Inc is seeking a Senior Medical Device R&D Engineer based in Brooklyn, New York. This full-time, on-site position involves leading the design and development of medical devices, ensuring compliance with FDA and ISO standards, and collaborating across multidisciplinary...SeniorFull time
$103k - $130k
...seeking a Sr. Clinical Research Associate to manage IVD and medical device clinical trials from start to finish. This fully remote role... ...clinical research experience, with the ability to navigate regulatory requirements. Competitive salary range of $103,000 to $130,000,...SeniorRemote job- Consigli Construction Co. is looking for a Senior M/E/P Estimator to manage estimates for complex, large-scale projects including conceptual estimates and value engineering. The ideal candidate will have a Bachelor's degree in a relevant field and at least 8 years of estimating...Senior
- ...A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy development for labeling, ensuring compliance, and managing cross-functional stakeholder reviews. Candidates...SeniorRemote work
$90k - $100k
Dormont Manufacturing Co is seeking a Senior International Regulatory Affairs Specialist to drive global market access for medical devices. In this hybrid role, you'll provide regulatory strategies and high-quality submissions for international markets. Candidates should...- Meridian Bioscience International Limited is seeking a Regulatory Affairs Specialist to support quality and regulatory processes for medical devices. The role involves ensuring compliance throughout the product lifecycle and providing regulatory guidance. Ideal candidates...Senior
- Initial Therapeutics, Inc. is seeking a Senior Manager for their Regulatory Affairs Advertising and Promotion team in the United States. This role involves managing regulatory activities for advertising and promotion of marketed products, ensuring compliance with FDA regulations...Senior
- A leading cancer treatment center in New York is seeking a Senior Regulatory Compliance Coordinator to oversee clinical trials and ensure compliance with regulatory standards... ...of 4 years of experience in regulatory affairs or clinical research and relevant certifications...Senior
- A leading healthcare institution in Bronx, New York, is seeking a Senior Regulatory Consultant to manage regulatory compliance for cancer clinical trials. This role involves... ...of 4 years of experience in Regulatory Affairs. Additional certifications such as SOCRA or ACRP...Senior
- Nuvation Bio, Inc. is hiring a Regulatory Affairs professional in New York to manage regulatory submissions and collaborate with teams for drug development. Candidates should have at least 10 years of experience in the biopharmaceutical industry, hands-on skills in regulatory...Senior
- Parexel International is looking for an experienced Senior Regulatory Affairs Consultant in the United States. This role involves managing complex projects, providing strategic advice, and delivering regulatory solutions to clients. The ideal candidate will have a minimum...Senior
$72k - $90k
A prominent healthcare provider in New York is seeking a Senior Regulatory Consultant to oversee the regulatory compliance of cancer clinical... ...and at least 4 years of experience in regulatory or clinical affairs. This position offers a salary range of $72,000 to $90,000,...Senior- BeiGene, Ltd. is seeking an AD, Regulatory Affairs CMC dedicated to developing and implementing global regulatory strategies for market access. You will manage CMC aspects through all development phases and coordinate with key stakeholders. The ideal candidate will have...Senior
$134k - $185k
...analyzing market trends. Applicants should possess a strong background in product or marketing management, preferably in the medical device industry. A bachelor’s degree in a relevant field is required, and an MBA is preferred. Location: United States, New Jersey. Salary...Senior- 6AM City, LLC is looking for a Clinical Research Associate (CRA) with 3-6 years of experience in CRA tasks such as remote monitoring, SOP creation, and protocol development. Ideal candidates should be flexible, able to troubleshoot independently, and must have experience...SeniorRemote workFlexible hours
- An established industry player is seeking a Senior Manager for Regulatory and Medical Affairs to drive strategy and ensure medical excellence in the Cell Therapy... ...experience in the pharmaceutical industry. You will lead multiple projects, navigate complex stakeholder...Senior
- Amgen SA is looking for a Regulatory Affairs Senior Associate to assist in creating and submitting regulatory documents essential for FDA compliance and submissions. The ideal candidate will support various regulatory activities, ensuring all documentation is accurately...Senior
- KS Engineers, P.C. is seeking a Senior Construction Inspector in New York, NY. The ideal candidate will have a Baccalaureate degree and at least 3 years of experience in construction inspection or management. Your role will involve reviewing inspection reports, ensuring...Senior
$110k - $135k
Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within life sciences and diagnostics. You will lead the creation of regulatory documents and provide guidance on product development while...SeniorRemote job- Scorpion Therapeutics is looking for a Sr Director of Global Regulatory Strategy in New Jersey. As a key member of the GRSP Extended Leadership... ...of pharmaceutical industry experience, including regulatory affairs. This role offers comprehensive health coverage and flexible...SeniorFlexible hours
$102k - $152k
Senior Regulatory Affairs Specialist (Columbia, MD) Hybrid - US - Columbia MD May 12, 2026 $102K... ...Regulatory Affairs Specialist will lead regulatory submissions and develop strategies... ...Cellular and Tissue-Based products (HCT/P) and for device-led combination products. The role...Senior- Sr Director, Global Regulatory Strategy, Neuroscience Responsibilities Key member of the GRSP... ...assessments. Serve as Global Regulatory Lead and US Regional Regulatory Lead for assigned... ...Identify issues impacting BMS/regulatory affairs/projects and provide strategies. Partner...SeniorFlexible hours
- ...in New York is seeking a Compliance Risk Assessment Officer to lead and manage the annual Compliance Risk Assessment process. This position... ...analytical skills, and the ability to present findings to senior stakeholders. Employees enjoy a competitive salary with a hybrid...Senior
$184.8k
...Hospitable, Inc is looking for a Senior Compliance Officer to lead their compliance initiatives. This role involves managing the SOC 2 Type II compliance program and rolling out PCI DSS compliance. The candidate should have significant experience in compliance programs...SeniorRemote work$82.92k - $150k
...A leading cryptocurrency exchange is seeking a Senior Compliance Officer to develop and implement compliance programs related to BSA/AML and KYC regulations... ...flexibility in a dynamic environment focused on regulatory compliance and risk mitigation. #J-18808-Ljbffr...SeniorRemote work$160k - $175k
...A leading banking institution is seeking a Senior Compliance Officer to support its consumer regulatory compliance functions. Based in New York, NY or Miami Lakes, FL, the role involves executing the Compliance Program, providing compliance resource expertise to business...SeniorFlexible hours
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