Description:
As an FDA Counsel II (Medical Products), you'll play a critical part in ensuring our medical products comply with all applicable FDA regulations. You'll partner closely with our Innovation, Research, and Design team and others to advise on innovative health products in areas of rapid growth, such as weight loss and at-home collection kits. You have a strong knowledge of FDA regulations, and either already have knowledge of or are eager to learn on the job about specialized areas of law such as compounded drugs, medical devices, and pharmacy. You're smart, eager to learn, and are comfortable working in a dynamic, evolving environment while handling several projects at the same time.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.
- 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.
