Senior Regulatory Affairs Executive

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