x
Get our mobile app
Fast & easy access to Jobstore
Use App
Congratulations!
You just received a job recommendation!
check it out now
Browse Jobs
Companies
Campus Hiring
Download App
Jobs in Singapore   »   Jobs in Singapore   »   Senior Regulatory Affairs Executive
 banner picture 1  banner picture 2  banner picture 3

Senior Regulatory Affairs Executive

Biobot Surgical Pte. Ltd.

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

Sharing is Caring

Know others who would be interested in this job?