Regulatory Affairs Specialist

Regulatory Affairs Specialist (Principal)

Position Summary
We are seeking an experienced Regulatory Affairs Specialist to support and guide the regulatory strategy for a portfolio of medical devices. This role will serve as a key advisor to executive leadership and provide regulatory insight across the product lifecycle, with particular emphasis on higher‑risk devices and global market considerations.

Key Responsibilities

• Provide strategic regulatory leadership for Class II and Class III medical devices from development through commercialization and lifecycle management.
• Interpret and apply global regulatory requirements to inform business and product strategy.
• Advise senior leadership and the Board of Directors on regulatory risks, opportunities, and compliance considerations.
• Contribute to the development and execution of regulatory strategies aligned with corporate objectives.
• Serve as a subject matter expert on regulatory frameworks, standards, and evolving regulatory expectations.
• Support cross‑functional teams by providing regulatory guidance related to design, clinical, quality, manufacturing, and post‑market activities.
• Represent regulatory interests in internal discussions and, as needed, external interactions with regulatory bodies or partners.
• Monitor regulatory trends and assess potential impacts to the organization's pipeline and long‑term strategy.

Qualifications

• 10+ years of experience in medical device regulatory affairs.
• Demonstrated experience supporting or leading regulatory strategy for Class II and Class III medical devices.
• Broad understanding of global medical device regulatory requirements and compliance expectations.
• Proven ability to communicate complex regulatory concepts to non‑regulatory stakeholders, including executives and board members.
• Strong strategic thinking, professional judgment, and stakeholder engagement skills.