Commercial Regulatory Affair & Project Lead, 12-month, CBD

Location Singapore
Discipline Healthcare & Medical
Job Reference BBBH131142_1694146718
Salary Negotiable
Consultant Name Fu Yee Chen, Lyn
Consultant Email
Consultant Contact No. 62325738
EA License No. 02C3423
Consultant Registration No. R1110796

Job Summary:

  • Coordinate and manage all related RA activities for the portfolio in Singapore
  • Act as a RA Project Manager for APAC regional projects

Job Scope:

  • Responsible for pre-market submission and post-market surveillance management of IVD medical device products for SG Affiliate
  • Support and develop regulatory submission plan for the region in collaboration with project team, manufacturing sites, supply chain, marketing and country manager
  • Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates
  • Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
  • Responsible for review of promotional material for Singapore
  • Track regulatory milestones in internal Regulatory database
  • Report submission status via defined Key Performance Indicators

APAC Regulatory Project Lead

  • Lead and support APAC region team on assigned projects (e.g. change notification, rebranding, site transfer, NPIs).
  • Track and maintain status of APAC regional projects by working closely with country Regulatory teams.
  • Share project status to identified stakeholders on a regular basis with appropriate scorecards.
  • Ensure timely execution of regulatory strategies as per plan, identify risk at an early stage and develop mitigation plans as needed.


  • Represents RA and/or APAC at relevant meetings
  • Support strategic Quality and Regulatory Affairs Goals and objectives.

Job Requirement:

  • BSc or equivalent, minimum of 5 years' experience in Regulatory Affairs in Medical Devices, ideally in IVDs
  • Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD).
  • Knowledge of and demonstrated experience in IVD Medical devices registration for Singapore
  • Project management and able to navigate in a cross functional environment
  • Knowledge of the APAC regulatory environment, including SaMD US FDA and regional digital health regulations and requirements, legislation, industry standards and guidance
  • Written and oral communication skills and attention to detail
  • Interpersonal skills, highest levels of integrity and diplomacy.
  • Capacity to maintain the highest levels of confidentiality. internally and externally

Additional Information:

  • Salary - Open for discussion
  • Contract duration: 12-month contract, renewable
  • Commencement Date: Immediate
  • Working days and hours: Mon to Friday, 9am to 6pm
  • Location: Bugis, DUO Tower

Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

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