Skills Alliance · 3 days ago
Vice President of Regulatory Affairs
New Hampshire, United States
Full-time
Hybrid
Director/Executive
10+ years expSkills Alliance is supporting a high‑growth oncology implantable device company developing breakthrough next‑generation cancer therapeutics. As VP of Regulatory Affairs, you will own and lead the regulatory strategy, guiding the company through critical approval processes for innovative oncology implant platforms.
RecruitingStaffing Agency
Hiring Manager
Hugh Cross
Responsibilities
Own and lead the regulatory strategy across the U.S. and global markets
Guide the company through pre‑clinical, IDE, pivotal trials, and ultimately PMA approval for a high‑risk Class III implantable device
Work cross‑functionally with R&D, Clinical, Quality, and Operations to shape the regulatory pathway
Directly influence clinical strategy, regulatory positioning, design controls, and global expansion as the company scales into commercialization
Qualification
Required
10+ years Regulatory Affairs experience in medical devices, including 5+ years in senior leadership roles
Proven success leading Class III implantable devices through IDE → PMA pathways
Strong track record managing FDA interactions (Q-Subs, Pre-Subs, IDE, PMA, labeling, design reviews)
Expertise in oncology, implantables, bioelectronics, or complex therapeutic systems
Deep understanding of 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and global regulatory frameworks
Experience collaborating with R&D, Clinical, Quality, and executive teams in a high-innovation setting
Exceptional communication and leadership skills to influence strategy at the C-suite and Board level
Benefits
Competitive Executive Package
Company
Skills Alliance
Skills Alliance is a staffing & consulting agency that mainly recruits life sciences and medical technology professionals.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-08-02Acquired
Recent News
Real Deals Magazine
2022-08-02
Company data provided by crunchbase