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Global Regulatory Lead

1 week ago

Singapore Andaman Medical Full time

Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. This role is responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Responsibilities

  • Investigate whether the Health Product is a medical device requiring registration with MOH, and determine its risk classification and route of submission.
  • Prepare and submit applications related to Initial, Renewal, Change Notification of medical device submissions, including follow-up until approval.
  • Promptly inform manufacturer if there's any feedback from Authority to ensure successful product registration.
  • Communicate with customers in response to their regulatory concerns.
  • Maintain regulatory database for the Company.
  • Conduct research and prepare Regulatory Intelligence Reports.
  • Monitor emerging trends in industry regulations and provide updates to the Marketing Manager.
  • Support sales teams in discussions with clients on regulatory matters.
  • Develop and maintain Standard Operating Procedures, local working practices, regulatory affairs policies and procedures.
  • Liaise with external parties on medical device regulatory requirements.

Requirements

To be successful in this role, you will need:

  • At least a Bachelor's Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
  • At least 2 years' experience in the medical device industry and especially in regulatory affairs.
  • Good management skills.
  • Fluent English with excellent writing and verbal communication skills.
  • Result-oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
  • Computer literate with advanced skills in Microsoft Office (Word, PowerPoint, etc.).
  • Able to operate in a multicultural environment.
  • A high level of autonomy at work, yet with a profound team spirit.