Director, Clinical Research & Regulatory Affairs

For our client, we are seeking a Director Clinical Research & Regulatory Affairs to join the team of a leader in the Healthcare space. This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross‑functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision‑making, and support sustainable growth within a healthcare environment.

Location:

New York, NY — US based candidates only, no visa sponsorship available

Compensation: $230,000 – $245,000 annually

• Lead company-sponsored clinical studies in compliance with Good Clinical Practice (GCP)
• Design clinical study protocols and statistical plans with cross‑functional teams
• Review and analyze clinical data to support product performance
• Develop and implement SOPs for clinical trials
• Manage all aspects of the Investigator Initiated Trials (IIT) program
• Recruit clinicians and research partners for clinical studies
• Manage and mentor clinical team members while identifying staffing and budget needs

• BS in Engineering or a Technical Field; advanced degree (PhD, MD, or equivalent) preferred
• 7-10 years in medical device or healthcare industry, with 6 years in clinical affairs or trial management
• Established network of KOLs and clinical research collaborators
• Strong knowledge of GCP, IRB/Ethics Committee requirements, and clinical study design
• Experience writing SOPs and clinical research documentation
• Excellent communication, leadership, and cross‑functional collaboration skills

• Comprehensive health insurance, including dental and vision coverage
• Employee Assistance Program for emotional and day‑to‑day support
• 401(k) plan with matching contributions
• Opportunity to participate in Employee Stock Purchase Plan (ESPP)
• Unlimited Paid Time Off plus 10 Holiday Days per year
• Parental Leave for bonding with family members
• Equity opportunities to encourage employee investment in the company
• Opportunity to contribute to a revolutionary healthcare product

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.