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