Senior Regulatory Affairs Executive

1 month ago


Singapore BIOBOT SURGICAL PTE. LTD. Full time
Roles & Responsibilities

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

Tell employers what skills you have

Annual Reports
CE marking
Leadership
FDA
Ability To Work Independently
Regulatory Affairs
Healthcare
Audits
Communication Skills
Change Control
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