Senior Regulatory Affairs Specialist

Key Qualifications

• Bachelor's degree in a scientific discipline or related field required.
• 3-5+ years of Regulatory Affairs experience within the medical device industry.
• Strong knowledge of global medical device regulations and product development processes.
• Experience preparing and supporting regulatory submissions for international markets.
• Understanding of quality systems and their relationship to regulatory compliance.
• Ability to interpret regulatory requirements and provide guidance to cross-functional teams.
• Strong technical writing, organizational, and project management skills.
• Excellent communication and stakeholder management abilities.
• Experience with Class III medical devices preferred.
• Cardiovascular device experience is highly desirable.

Roles & Responsibilities

• Prepare, submit, and maintain global regulatory filings, registrations, annual reports, and submission amendments.
• Support interactions and correspondence with global regulatory authorities and notified bodies.
• Partner with product development and sustaining engineering teams to ensure regulatory requirements are incorporated throughout the development process.
• Interpret regulatory requirements related to product design, clinical studies, testing, labeling, and post-market activities.
• Support adverse event reporting, Medical Device Reports (MDRs), vigilance reporting, and other regulatory communications.
• Review and provide regulatory input on risk management documentation, technical reports, and related product documentation.
• Ensure product labeling remains compliant with applicable global regulations.
• Monitor evolving regulatory requirements and communicate potential impacts to the business.
• Review document change orders and support regulatory assessments for product changes.
• Participate in internal and external audits as needed.
• Maintain regulatory intelligence and contribute to continuous improvement of regulatory processes and procedures.

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Competitive PTO and paid holidays
• Career development and advancement opportunities
• Collaborative and mission-driven culture
• Opportunity to work on innovative medical technologies with global impact