Medical Device _ RA Manager

Client Description

• A leading medical device company known for its commitment to innovation, quality, and patient safety. The company operates on a global scale and maintains a strong presence in various international markets.

• Ensure compliance with FDA, CE, ISO 13485, and other regulatory standards for Class II and III medical devices.
• Prepare and submit regulatory documents for product registrations and approvals across international markets.
• Monitor and interpret regulatory changes, ensuring that products maintain ongoing compliance.
• Conduct internal regulatory audits to assess adherence to Quality Management System (QMS) and regulatory requirements.
• Collaborate with cross-functional teams (e.g., Product Development, Quality Assurance) to ensure regulatory requirements are met throughout the product lifecycle.
• Provide regulatory training and guidance to staff and stakeholders, ensuring awareness of relevant regulations.

• 5+ years of experience in Regulatory Affairs within the medical device industry
• Fluent in English
• Experience in regulatory submissions for Class II and III medical devices
• Familiar with ISO 13485 and Quality Management Systems (QMS)、QSD

• Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.
• Additional certifications or training in Regulatory Affairs or Quality Management Systems are a plus.