Remote FDA Counsel II (Medical Products)

Summary

Join Ro as an FDA Counsel II (Medical Products) to ensure medical products comply with all applicable FDA regulations and partner closely with the Innovation, Research, and Design team.

Requirements

• 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

Responsibilities

• Provide expert legal counsel on a broad range of FDA regulatory matters related to medical products
• 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

Benefits

• 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