Job Description – Regulatory Affairs Executive
· Ensure compliance with applicable regulatory requirements and standards for medical device.
· Assist in the drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards.
· Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification.
· 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;
- Preferred 2 to 3 years of experience in regulatory affairs within medical device , pharmaceutical or biotechnology industry;
- Familiar with relevant regulatory guidelines and standards eg ISO 13485;
- 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
