Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist manages international regulatory activities for medical devices, focusing on submissions, registrations, and lifecycle management in the UK, Japan, and Latin America.

Responsibilities

• Prepare and coordinate regulatory submissions, amendments, and renewals across multiple markets.
• Manage product registration and lifecycle activities in Latin America, Japan, and the UK, ensuring compliance and market access.
• Conduct regulatory assessments for product and Quality System changes, advising on necessary notifications or approvals.
• Review product labeling and documentation for compliance with international regulations.
• Track registration commitments, renewals, and regulatory changes to maintain market authorization.
• Support audits, inspections, and process improvements within regulatory functions.
• Provide guidance on international regulatory requirements and communicate effectively with cross-functional teams.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Engineering, or Life Sciences.
• Minimum of 5 years’ experience in medical device regulatory affairs.
• Expertise in managing submissions in the UK, Latin America, and Japan.
• Familiarity with ISO 13485, MDSAP, and other international standards.
• Strong technical writing, communication, and attention to detail.

Requirements

• Experience working with regulatory authorities, managing change assessments, and supporting international markets.
• Knowledge of EU MDR, Health Canada, and TGA regulations is preferred.
• Some travel required.

Benefits

• Comprehensive benefits
• Potential eligibility for equity

Pay

Competitive pay.