FDA Counsel II (Medical Productts)
New York, NY or Remote
What You'll Do:
- Provide expert legal counsel on a broad range of FDA regulatory matters related to medical products, including compounded products and medical devices, and in areas such as product development, production, Q&S, labeling, and advertising to ensure full compliance with FDA regulations.
- Cover legal issues arising with respect to Ro pharmacies.
- Draft, review, and negotiate a variety of agreements, including supply agreements.
- Develop and implement regulatory strategies to support the company’s business objectives.
- Participate in interactions with the FDA and other regulatory agencies.
- Stay abreast of changes in FDA regulations and industry trends, and monitor enforcement actions and relevant litigation.
- Collaborate closely with cross-functional teams, including R&D, clinical operations, quality assurance, and marketing/growth.
- Anticipate and proactively address potential regulatory issues.
- Demonstrate a willingness to grow and expand your expertise into adjacent areas of law to support the company’s evolving needs.
What You'll Bring to the Team:
- Juris Doctor (JD) from an accredited law school.
- Active member in good standing of a state bar association.
- Ideally a Doctor of Pharmacy (PharmD) with prior work experience as a pharmacist.
- At least five years of experience practicing FDA law, with a focus on medical products (drugs, compounded products, and devices) development, commercialization, and marketing.
- Exceptional analytical, research, and writing skills.
- Strong communication and interpersonal skills, with the ability to build relationships across all levels of the organization.
- Business-oriented mindset with the ability to translate legal advice into practical solutions.
- Adaptable and able to thrive in a fast-paced, dynamic environment.
- Self-starter with the ability to manage multiple projects simultaneously and meet deadlines.
- Team player with a collaborative work ethic.
- Willingness to think strategically and also weigh in on operations and implementation.
- Passion for the telehealth industry and a desire to make a meaningful impact.
- Demonstrated interest in expanding your legal knowledge beyond core FDA practice areas.
We've Got You Covered:
- Full medical, dental, and vision insurance + OneMedical membership
- Healthcare and Dependent Care FSA
- 401(k) with company match
- Flexible PTO
- Wellbeing + Learning & Growth reimbursements
- Paid parental leave + Fertility benefits
- Pet insurance
- Student loan refinancing
- Virtual resources for mindfulness, counseling, and fitness
Job Profile
401(k) with company match Dental Flexible PTO Medical Medical, dental, and vision insurance OneMedical membership Paid parental leave Pet Insurance Student Loan Refinancing Vision Insurance Wellbeing reimbursements
Tasks- Collaborate with cross functional teams
- Develop regulatory strategies
- Draft and negotiate agreements
- Monitor regulatory changes
- Provide legal counsel on FDA matters
Analytical Collaboration Communication Compounded drugs Contract Negotiation Dynamic Environment FDA regulations Healthcare Interpersonal Legal counsel Medical Devices Medical products Operations Product Development Project Management Quality Assurance Regulatory Strategies Research Strategic Thinking Telehealth Writing
Experience5 years
EducationDoctor of Pharmacy Juris Doctor
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9