FDA Regulatory Counsel: Drugs, Biologics & Medical Devices
BCG Attorney Search
BCG Attorney Search seeks a mid-level associate for its Washington, DC office. This role requires a minimum of 4 years of experience to support FDA regulatory matters in the life sciences sector. The associate will engage in strategic counseling, draft regulatory submissions, and ensure compliance with FDA requirements. A Juris Doctorate degree and admission to the relevant jurisdiction's bar are mandatory. Candidates should possess strong regulatory drafting skills and an analytical mindset. #J-18808-Ljbffr BCG Attorney Search
- ...The team advises life sciences companies on U.S. Food and Drug Administration (FDA) regulatory matters involving drugs, biologics, medical devices, and combination products. The role involves strategic counseling across the FDA medical product development lifecycle,...RegulatoryMedical device
- ...seeking a midlevel associate for its Food & Drug Law practice in Washington, D.C. The... ...such as food, dietary supplements, and medical devices on regulatory matters. The role involves various responsibilities, including FDA counseling, regulatory compliance strategy, and...RegulatoryMedical device
$135.3k - $376.8k
## Director, Regulatory Affairs - Regenerative Medicine & Biologics QualityApplylocations: Washington... ...lifecycle solutions for the medical device and diagnostics... ...Regulatory Affairs related to FDA oversight of various... ...products (HCT/Ps, drugs and/or biologics, medical...RegulatoryMedical deviceFull timePart timeWork experience placementImmediate startWorldwide- ...and Development Authority (BARDA) in Washington, DC. The role requires a minimum of 10 years' experience in drug development and extensive knowledge of regulatory compliance. The chosen candidate will guide quality issues, lead auditing activities, and ensure compliance...Regulatory
$217k - $315k
...Preferred qualifications Experience with counseling companies on health or wellness... ...including but not limited to software as a medical device and physical medical devices. Ability... ...with specialty teams, including Regulatory Affairs, Trust and Safety, and Privacy...RegulatoryMedical deviceTemporary work$96.13k - $135k
Pharmaceuticals, Drugs, and Biotechnology Specialist (Intelligence Analyst 3) Location: Washington... ...and illicit drugs, pharmaceuticals and medical devices, supply chain issues related to pharmaceuticals and biotechnology, regulatory and policy issues, foreign biotechnology...RegulatoryMedical deviceFull timeWork experience placementWork at officeLocal areaImmediate start- ...leading scientists, medical and technical... ...and contact us. FDA Veterinary Medical... ...data included in regulatory submissions, as relevant... ...review of medical devices. Such submissions... ...and Food and Drug Administration Staff... ...evaluation within biological systems, such as "...RegulatoryMedical deviceFull timeFor contractorsWork at officeRemote workMonday to Friday
- ...associate to join its Food & Drug Law practice in Washington, D... ...the food, dietary supplement, medical device, cosmetic, and OTC drug industries on regulatory, compliance, advertising, and... ...matters. Duties Provide FDA regulatory counseling on product classification, labeling...RegulatoryMedical deviceFixed term contract
- ...of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit... ...Ensure EMPQ activities align with FDA, EU GMP, ISO 14644, and internal quality... ...~ Excellent technical writing and regulatory communication skills ~ Ability to...RegulatoryMedical deviceFull timePart timeFlexible hours
- Overview The Director, Regulatory Science and Policy, works closely with... ...in areas that are focused on FDA‑related issues. The Director... ...of two or more novel drugs, informing regulatory science... ...fees for prescription drugs and medical devices. The Director, Regulatory Science...RegulatoryMedical deviceWork at office
$107.8k - $300.4k
## Associate Regulatory Affairs Director, SpineApplylocations: Washington... ...solutions for the medical device and diagnostics industry. Together... ...of medical devices, drugs and/or biologics, developing regulatory deliverables... ...with regulations (e.g., FDA, Notified Body, ISO 13485)....RegulatoryMedical deviceFull timePart timeWork experience placementImmediate startWorldwide- ...RPR & LS associated with drugs, biologics, combination products, OTC, medical devices, and more. The role provides compliance and regulatory advisory services,... ...compliance officers, general counsel, internal auditors,... ...promotional tactics aligned with FDA requirements....RegulatoryMedical deviceWork at office
- ...leading scientists, medical and technical... ...specifically the Division of Regulatory and Quality Affairs... ...experience in drug development, manufacturing... ...for drug and biologic development and... ...manufacture. Experience with device and/or IVD development, including FDA Quality Management...RegulatoryMedical deviceFor contractors
- Sr. Regulatory Affairs SME - Medical Devices Background A Regulatory Affairs Analyst/subject... ...consequences of chemical, biological, radiological, and nuclear... ...development and procurement of drugs, vaccines and other... ...products which are regulated by FDA's Center for Devices and...RegulatoryMedical deviceContract workFor contractors
$260k - $365k
...to our communities. Our FDA + Healthcare Regulatory and Compliance Practice Group... ...life‑cycle approach, we counsel domestic and international... ...market representation in the medical device, pharmaceutical, food and... ...representing food, drug, supplement, cosmetic and/...RegulatoryMedical deviceFlexible hours$200k - $250k
...LLP is seeking an experienced FDA consultant to work with the... ...inspections at pharmaceutical and medical device manufacturing sites. This... ...the client including legal, regulatory, quality, manufacturing, and... ...Bachelor’s degree in chemistry, biology, pharmacy, engineering, or a...RegulatoryMedical deviceWork at officeLocal areaRemote work$143k - $200k
...real estate. Role Overview: Counsel, Operating Businesses Irvine,... ...product development, piracy, and regulatory compliance. Provide practical,... ...healthcare coverage: Medical / Vision / Dental / Prescription Drug ~ Life, legal, and supplementary...RegulatoryFull timeContract workWork at officeMonday to Friday- ...Government Services, Inc. is looking for a Sr. Regulatory Affairs Subject Matter Expert to provide... ...will leverage extensive experience in device development and regulatory affairs,... ...responsibilities include ensuring compliance with FDA regulations, providing guidance on...RegulatoryMedical device
- ...Junior to Mid-Level Associate for its Medical Devices group. This position involves advising... ...on medical device regulation, preparing FDA submissions, and managing compliance matters... ...should have an interest in FDA regulatory law, a law degree, and be admitted to the...RegulatoryMedical device
- Exponent Inc. is seeking a Manager-level FDA Regulatory Scientist for our Chemical Regulation and Food Safety Practice in Washington, DC. This role involves managing projects related to FDA drug applications, requiring extensive regulatory knowledge and communication skills...Regulatory
$75k - $95k
...compliance with all applicable regulatory guidelines. Failure to... .... Preferred Qualifications: Medical device sales and/or clinical education... ...Bachelor's degree in Nursing, Biology, Kinesiology or other... ...candidates will be subject to a drug test as a pre-employment requirement...RegulatoryMedical deviceFull timeWork experience placementWork at officeNight shift- ...empowers biotech, med device, and... ...domain expertise in regulatory sciences, clinical... ...pharmacovigilance, medical information, and R... ...most high-profile drug and device programs... ...understanding of FDA (and other regulatory... ...documents for drugs, biologics, and/or medical devices...RegulatoryMedical deviceContract workWork at officeRemote work
$175k - $185k
...legislative and policy advocacy, legal and regulatory compliance counsel, representation in administrative... ...field (environmental science, biology, chemistry, engineering, etc.) will be... ...competitive benefits package, including medical, dental, and vision insurance; a 401(...RegulatoryFull timeWork at officeFlexible hours3 days per week$235k - $310k
...seeks a junior to mid-level associate for its Medical Devices group. This role entails guiding clients through FDA regulations and managing compliance issues in a... ...practice. Responsibilities include advising on regulatory pathways, supporting premarket applications, and...RegulatoryMedical deviceWork at office$165.5k - $291.85k
## Senior Counsel - AMLApplylocations: DC - Washington: AL - Birminghamtime type:... ...advising on client diligence, responding to regulatory inquiries and exams, and addressing... ...for full-time employees include: medical/prescription drug coverage (with a Health Savings Account...RegulatoryFull timeTemporary workPart timeWork experience placementWork at office$143k - $200k
Counsel, Operating Businesses - CoStar Group - Arlington, VA or Irvine, CA... ...product development, piracy, and regulatory compliance. Provide practical, risk... ...Comprehensive healthcare coverage: Medical / Vision / Dental / Prescription Drug Life, legal, and supplementary insurance...RegulatoryFull timeContract work- ...Deputy General Counsel, Product About the Company... ...Health Care Medical mHealth Wellness About... ...and medical devices. This role involves... ...compliance with complex regulatory requirements,... ...set by the Food and Drug Administration.... .... Experience with FDA-regulated software...RegulatoryMedical device
- Biomedical Engineer/Medical Device Subject Matter Expert Full-time Pharmaceutical... ...and “weaponized” chemical, biological, and radiation terrorist... ...that will develop, gain FDA approval and produce for... ...the engineering development, regulatory compliance, and clinical usage...RegulatoryMedical deviceFull timeContract work
- Position Overview As a Senior Counsel in PNC’s Corporate Governance organization... ...consulting, legal practices, legal risk, regulatory compliance, risk assessments.... ...or individual performance. Benefits Medical and prescription drug coverage (with Health Savings Account...RegulatoryTemporary work
- ...is looking for a skilled professional to support analyses of medical devices in Bethesda, Maryland. This role involves coordinating with... ...writing detailed documents, and providing consultation for regulatory submissions related to biomedical engineering. The ideal candidate...RegulatoryMedical deviceRemote jobFlexible hours
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