Job Description - Senior Regulatory Affairs Executive
- Drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards , specifically EU MDR 2017/745
- Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification (eg US FDA, SG HSA, AUS TGA etc)
- Ensure compliance with applicable regulatory requirements and standards for medical device.
- Work closely with internal team for documentation and information gathering.
- Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.
- Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.
- Participate in internal / external audits as part of the audit team (including supplier audit)
- Maintain up-to-date knowledge of regulatory requirements and changes
- Ensure post-market surveillance obligations are complied with regulations
- Any other ad-hoc assigned
Qualification Requirement
- Bachelor's degree in biological science, biological engineering, pharmacy or related field
- 4-5 years of experience in medical device regulatory affairs with experience in FDA 510(k) or CE marking
- Familiar with relevant regulatory guidelines and standards such as ISO 13485, EU MDR 2017/745
- Strong attention to detail and organization skills
- Ability to work independently and as part of a team
- Strong problem-solving and analytical skills
- Excellent written and verbal communication skills
