Senior Regulatory Affairs SME - Medical Devices & FDA
Tunnell Government Services, Inc.
Tunnell Government Services, Inc. is looking for a Sr. Regulatory Affairs Subject Matter Expert to provide vital regulatory support to BARDA in Bethesda, MD. The candidate will leverage extensive experience in device development and regulatory affairs, especially in the area of diagnostic devices. Key responsibilities include ensuring compliance with FDA regulations, providing guidance on submissions, and collaborating with cross-functional teams. Ideal candidates must possess a strong background in life sciences and communication skills, with a minimum of 15 years' experience in the field. #J-18808-Ljbffr Tunnell Government Services, Inc.
- ...Ophthalmology SME Bethesda, MD Tunnell Government Services... ...scientific services to the FDA Center for Devices and Radiological Health (... ...regulation and approval of medical devices. In general, these consultants... ...assist the CDRH with their regulatory responsibilities. This...Medical deviceFor contractorsWork at officeRemote work
- ...Church School is seeking a Sr. Regulatory Affairs SME for the Biomedical Advanced Research... ...regulatory expertise for medical countermeasures and compliance with FDA regulations. Candidates should have... ...over 15 years of experience in device development, substantial knowledge...SeniorMedical device
- ...s leading scientists, medical and technical experts,... ...specifically the Division of Regulatory and Quality Affairs: Essential Duties... ...matter expert (SME). Provide assessments... ...manufacture. Experience with device and/or IVD development, including FDA Quality Management...Medical deviceFor contractors
$126k - $178k
...lasting relationships with medical professionals and... ...transform patient care with devices supported by clinical... ...objective of the Senior Product Manager, Field... ...on clinical evidence, FDA regulatory approvals, and market... ...marketing, and medical affairs teams to ensure integrated...SeniorMedical deviceWork experience placementWork at officeNight shift$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to support the Medical Solutions team by providing regulatory expertise across various medical devices. This remote position involves preparing regulatory submissions, collaborating on international strategies...SeniorMedical deviceRemote work- Amgen is seeking a Regulatory Affairs Senior Associate in Washington, DC, to assist in the preparation and submission of regulatory documents and... ...collaborating with various teams and ensuring compliance with FDA regulations. The ideal candidate holds a Masters degree or...SeniorFlexible hours
- ...industry's leading scientists, medical and technical experts, and... ...Officer (Orthopedic Surgeon) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH... ...to assist the CDRH with their regulatory responsibilities. This candidate...Medical devicePermanent employmentTemporary workFor contractorsWork at officeRemote work
- ...Engineer to join our team and enhance patient care through modern medical devices. This role involves designing, developing, and maintaining... ...Master’s degree in Biomedical Engineering, and expertise in regulatory requirements. A comprehensive benefits package including...SeniorMedical device
$150k - $180k
Bridge Defense is seeking an Executive Officer (XO) Subject Matter Expert (SME) to support national security issues. This role involves analyzing defense strategies, creating recommendations, and collaborating with various stakeholders. The successful candidate will need...Senior$240k - $300k
...-eluting technologies to improve the interface between medical devices and the patients who rely on them. How we work matters... ...constant state of audit readiness and compliant with all FDA and international regulatory requirements for combination products. Foster a culture...Medical deviceFull timeRemote workShift work- ...Cadwalader in Washington, DC seeks a junior to mid-level associate for our Medical Devices group within the Food, Drug, Medical Device and Agriculture practice. You will handle FDA regulatory matters across pre-market and post-market work, including 510(k)s, IDEs, De...Medical device
- ...industry's leading scientists, medical and technical experts,... ...you and contact us. FDA CDRH – Ophthalmology – Retinal Disease SME Position Description... ...mission of the FDA Center for Devices and Radiological Health... ...the CDRH with their regulatory responsibilities. This...Medical deviceFor contractorsWork at officeRemote work
- PVH (Tommy Hilfiger/Calvin Klein) seeks a Regulatory Scientist (0696) to assess regulatory submissions and compliance across FDA frameworks. The role emphasizes applying knowledge of FDA laws, cGMP, and auditing practices to ensure product lifecycle integrity within a...Senior
$144k - $209k
...seeking a qualified candidate for the Digital Health Regulatory Quality and Strategy team in Washington, DC. This role... ...have at least five years of experience in regulatory affairs, particularly within medical devices and software. This position offers a competitive...SeniorMedical device- ...experience in both patent prosecution and litigation. Experience with patents in the biotechnology, pharmaceutical, gene therapy, medical device and digital health industries. Knowledge of patent portfolio management and development, competitive landscape analyses, and...SeniorMedical deviceWork at office
- Overview The Director, Regulatory Science and Policy, works closely... ...Science Policy and Government Affairs (and Chief Policy Officer)... ...in areas that are focused on FDA‑related issues. The... ...for prescription drugs and medical devices. The Director, Regulatory Science...Medical deviceWork at office
- ...Support the completion of the following LBE Projects: Equipment/systems lifecycle management support for the commercial launch of Medical Device. Transition activities supporting new systems/equipment/components for perfusion services/devices used at facilities, facility...SeniorMedical deviceFor contractors
$85k - $100k
...group, specifically the Forensic Data & Analytics (FDA) team, focuses on high-profile investigations, regulatory compliance, and financial crimes. We excel in... ...Chicago, and Washington, D.C. Role Overview The Senior Associate is a hands‑on technical role designed for...SeniorVisa sponsorship- ...professional growth are at the forefront. Aretum is seeking a Senior Cloud and Technology Modernization SME to provide senior-level expertise in Federal IT... ...initiatives Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance...SeniorTemporary workLocal area
- Leidos has a new opportunity for a Portfolio Analysis & Integration SME in Bethesda, Maryland. The role includes monitoring IT portfolios, supporting strategic direction, and providing recommendations for decision-making. The ideal candidate should have a BS degree with...SeniorFlexible hours
- Senior Associate Regulatory Affairs CMC In this vital role you will facilitate product development and global... ...RA CMC teams as well as the device team for specific strategies or activities... ...pharmaceutical/biotech, healthcare, medical device, or scientific experience OR...SeniorMedical deviceFlexible hours
- Noblis is seeking an experienced Management Analyst SME in Bethesda, MD. The role involves identifying critical requirements, shaping priorities, and translating them into actionable projects for national security. Key responsibilities include portfolio management, strategic...Senior
$260k - $365k
...inclusive workplace, and commitment to our communities. Our FDA + Healthcare Regulatory and Compliance Practice Group We advise clients in the... ...pre‑product launch to post‑market representation in the medical device, pharmaceutical, food and dietary supplement,...Medical deviceFlexible hours- ...experienced expert consultant in ophthalmology to assist the FDA CDRH. This fully remote role requires a Doctor of Medicine with... ...interpersonal and communication skills, familiarity with ophthalmic medical devices, and a deep understanding of current clinical practices in...Medical deviceRemote job
- International Executive Service Corps is seeking an SME II (Records Management) in Bethesda, MD. This position requires an advanced degree in Records Information Management and 5 years of experience, or a bachelor's degree with 10 years of experience. The ideal candidate...Senior
- ...Together, we can be our strongest. Overview We are seeking a Senior Manager, Field Operations & Last Mile to lead and oversee... ...Experience in consumer electronics, fitness equipment, appliances, medical devices, furniture, or other large‑format installation environments...SeniorMedical deviceSeasonal workLocal areaWork from homeShift work
- ...Surgical Oncologist - FDA Bethesda, MD Tunnell Government... ...'s leading scientists, medical and technical experts, and human... ...mission of the FDA Center for Devices and Radiological Health (CDRH... ...to assist the CDRH with their regulatory responsibilities. This candidate...Medical deviceFor contractorsWork at officeRemote work
- ...Medical Officer - Plastic Surgeon Tunnell Government Services, Inc. is providing... ...professional and scientific services to the FDA Center for Devices and Radiological Health (CDRH) with... ...to assist the CDRH with their regulatory responsibilities. This candidate should...Medical deviceFor contractorsWork at officeRemote work
- A leading technology firm is seeking a Technical SME in Washington, DC to support the Department of Veterans Affairs' Electronic Health Record Modernization program. This role involves advising on technical matters, resolving complex integration issues, and ensuring systems...SeniorRemote job
- ...the industry's leading scientists, medical and technical experts, and human capital... ...for you and contact us. Sr. Regulatory Affairs SME - Medical Devices Background: A Regulatory Affairs... ...are products which are regulated by FDA's Center for Devices and Radiological...SeniorMedical deviceContract workFor contractors
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