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Senior Regulatory Affairs Specialist at Andaman Medical

Position Senior Regulatory Affairs Specialist
Posted 29 Jul 2026
Expired 28 Aug 2026
Company Andaman Medical
Location Singapore | SG
Job Type Full Time

Job Description:

Latest job information from Andaman Medical for the position of Senior Regulatory Affairs Specialist. If the Senior Regulatory Affairs Specialist vacancy in Singapore matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Andaman Medical for the position of Senior Regulatory Affairs Specialist below matches your qualifications.

Job Overview

This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Senior Regulatory Affairs Specialist is expected to drive best practices in office and administrative management within the organisation to maximise efficiency and growth. The main responsibility is to proactively support the organisation in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.

Responsibilities

Senior Regulatory Affairs Specialist

  • Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
  • Preparing and submitting applications related to Initial, Renewal, Change Notification of medical device submissions, including follow up until approval.
  • Promptly inform manufacturer is there’s any feedback from Authority to ensure successful product registration.
  • Communicating with customers in respond to their regulatory concerns.
  • Maintain regulatory database for the Company.
  • Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
  • Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
  • Assist sales team in discussion with client on regulatory related matters (when required).
  • Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Liaising with external parties on matters relating to medical device regulatory requirements.
  • Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
  • Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

Qualifications

  • At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology,
  • Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as pharmacist/apothecary.
  • Minimum of 5 years of regulatory affairs experience in medical devices and /or IVD's, food supplements and cosmetics

Key Competencies

  • Good management skills
  • Fluent English and Mandarin 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, Power Point, etc..)
  • At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move.
  • Able to operate in a multicultural environment.
  • High level of autonomy at work, yet with profound team-spirit

Job Info:

  • Company: Andaman Medical
  • Position: Senior Regulatory Affairs Specialist
  • Work Location: Singapore
  • Country: SG

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Senior Regulatory Affairs Specialist at the office Singapore above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.

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