Regulatory Affairs Specialist - Medical Devices

Role Overview

The Senior Regulatory Affairs Specialist focusing on Medical Devices will provide essential support to regulatory planning and adherence throughout the lifecycle of aesthetic medical device products.

Key Responsibilities

• Oversee product registration activities in diverse geographic markets.
• Prepare and compile thorough technical files and regulatory submissions.
• Maintain and update device documentation to reflect current standards and regulations.
• Ensure full conformance with FDA requirements and ISO 13485 standards.
• Collaborate with various departments regarding design modifications, label revisions, and risk evaluations.
• Engage in external audits and regulatory inspections supporting compliance efforts.

Qualifications and Requirements

• Possess between 5 to 7 years of regulatory affairs experience within the medical device sector.
• Hold a bachelor’s degree in a related field.
• Demonstrate comprehensive knowledge of FDA regulations and ISO standards.
• Strong technical documentation and regulatory strategy skills are required.
• Capable of managing multiple concurrent projects effectively.
• Familiarity with European Union Medical Device Regulation (EU MDR) and Asia-Pacific regulatory frameworks is advantageous.

Additional Information

This position offers a hybrid working arrangement combining onsite and remote flexibility. The role provides a competitive wage along with a full benefits package to support employee wellbeing.