Principal Regulatory Specialist

Leading complex medical device regulatory programs is no small task — and this role owns it end‑to‑end. As the Principal Regulatory Affairs Specialist, you orchestrate cross‑functional collaboration, guide technical decision‑making, and keep the organization aligned with global regulatory expectations.

• Tackle complex regulatory and technical challenges with deep expertise in medical device manufacturing and the full product lifecycle.
• Lead compliance initiatives, translate technical guidelines, and support pre‑market requirements with clarity and confidence.
• Educate and empower business partners on regulatory expectations and best practices.
• Guide a team of subject matter experts supporting global regulatory submissions.
• Review submission content for technical accuracy and compliance across worldwide markets.
• Manage technical inquiries tied to submissions, registrations, licenses, clearances, approvals, and global market readiness.
• Drive regulatory strategy for product changes and new innovations in partnership with regional and engineering teams.
• Collaborate with Engineering, R&D, and Quality to build and maintain standards strategies, risk management plans, and hazard analyses.
• Improve design documentation processes to elevate efficiency and compliance.
• Communicate clearly across departments and partner effectively during audits and inspections.
• Own SOP creation, updates, and training for key teams.

• Bachelor’s degree plus 7+ years in medical device regulatory affairs.
• Hands‑on experience engaging with regulatory authorities on premarket and compliance activities.
• Strong project leadership, analytical thinking, and the ability to thrive under pressure.
• Deep understanding of manufacturing, change control, engineering concepts, and scientific terminology.
• Excellent written and verbal communication skills, interpersonal strength, and proven ability to lead in a team environment.
• Familiarity with FDA and global regulatory expectations, plus sharp organizational and documentation abilities.

This role fuels innovation, supports global access, and directly contributes to better outcomes for patients with critical needs. It’s high‑impact work in a mission‑driven, fast‑growing environment.