Associate Principal Scientist, Global Regulatory Lead (Medical Devices)

Location: Florham Park, New Jersey, USA; US and Puerto Rico residents only

Annual salary: $125,400–$213,100

Company

hirify.global is a global healthcare company focused on women's health, biosimilars, and a diverse portfolio of health solutions.

What you will do

• Develop and implement worldwide regulatory strategies for medical devices and combination products, including CMC considerations.
• Serve as the accountable global point of contact for regulatory strategy across development and marketed products.
• Lead the preparation, review, submission, and maintenance of CMC components, post-approval supplements, annual reports, renewals, and responses to health authority questions.
• Lead Global Regulatory Teams and coordinate cross-functional support for complex programs and products throughout their lifecycle.
• Interact with the US FDA, EMA, EU regulatory agencies, subsidiaries, and regional colleagues on registration requirements and regulatory strategy.
• Review and approve regulatory submissions, study protocols, clinical reports, investigator brochures, and marketing applications; provide risk assessments and strategic advice.

Requirements

• Ph.D., Pharm.D., or M.D. with at least 3 years of relevant drug development experience, preferably including 3 years in regulatory affairs; or M.S. or B.S. with at least 5 years of relevant device or drug development experience, primarily in regulatory affairs.
• Fluency in written and spoken English.
• Regulatory experience with worldwide health authorities, especially US FDA and EU regulations.
• Experience with regulatory product and compliance management, including preparation, submission, and maintenance of applications.
• Strong scientific writing, communication, negotiation, critical thinking, strategic planning, and problem-solving skills.
• Experience building and leading high-performing cross-functional teams, with knowledge of medical devices and combination products preferred.

Culture & Benefits

• Regular employee status with full-time employment.
• US benefits include retirement savings, paid vacation and holidays, paid caregiver, parental and medical leave, and medical, prescription, dental, and vision coverage.
• No relocation is provided.
• Employees must satisfy applicable travel and credentialing requirements, including vaccination prerequisites.