Regulatory Affairs Specialist - Medical Devices

About the role

Support regulatory strategies and compliance throughout the product lifecycle of aesthetic medical devices.

Responsibilities

• Manage product registrations across multiple regions.
• Prepare technical documentation and submissions.
• Update device files to ensure compliance with regulations such as FDA and ISO 13485.
• Collaborate with cross-functional teams on design changes, labelling updates, and risk assessments.
• Participate in audits and inspections.

Requirements

• 5-7 years of experience in regulatory affairs within the medical device industry.
• Relevant bachelor’s degree.
• Knowledge of FDA and ISO standards.

Skills

• Strong technical writing and regulatory strategy skills.
• Ability to manage multiple projects.
• Familiarity with EU MDR and APAC regulations (preferred).

Benefits

• Hybrid work model.
• Competitive salary.
• Comprehensive benefits package.