The Role
We are looking for an enthusiastic regulatory affairs associate with strong work ethics to join our company. The successful applicant will join our dynamic and friendly team, overseeing the regulatory aspect of medical device and diagnostic service development.
Key Responsibilities
- Ensure personal and team compliance with company values, quality system procedures, policies and relevant medical device standards and regulations
- Establish strategies for national/international approval and certification of medical device and diagnostic services
- Prepare and submit documents/technical files for regulatory approvals in major countries
- Ensure products comply with regulations and post-marketing management
- Manage and coordinate with diverse stakeholders, including regulatory agencies, CRO and government bodies
Skills and Experience
Essential skills & experience
- Tertiary qualifications in law, science, medicine, engineering, pharmacy, microbiology or other relevant scientific discipline and professional experience in regulatory affairs or in quality management systems relating to medical devices
- Experience in managing people and/or projects across different countries and cultures
- Highly developed communication and interpersonal skills
- Extensive knowledge and understanding of regulatory requirements of key jurisdictions is essential (though some may be acquired after being appointed to this role), such as for South Korea, USA, EU, Japan and China
- >3 years of experience in regulatory affairs role
- Fluency in both written and spoken Korean and English
Desired skills & experience
- Major in Science, Engineering, Pharmacy and Biotechnology preferred
- Experience in RA role for medical device and/or diagnostic services (especially in the U.S. market) will be highly regarded
