PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.
With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.
This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.
We are currently looking for a Regulatory Affairs Lead/Manager to join us in a permanent role, based in Singapore, with responsibility across Singapore, Thailand, Malaysia and Taiwan.
Key Attributes/Responsibilities
- 8–12+ years of experience in Medical Device Regulatory Affairs and/or Quality, including at least 2–3 years in a people-management, regional leadership or senior ownership capacity.
- Strong working knowledge of ISO 13485 and hands-on experience with at least two of the following regulatory frameworks: HSA Singapore, Thai FDA, MDA Malaysia and TFDA Taiwan.
- Lead the Regulatory Affairs and Quality function across Singapore, Thailand, Malaysia and Taiwan, providing regional ownership of regulatory compliance, quality performance and market access strategy.
- Develop and execute regulatory strategies for medical device registrations, renewals, variations, product changes and lifecycle management across HSA, Thai FDA, MDA and TFDA requirements.
- Act as the senior regulatory point of contact for complex submissions, Health Authority queries, regulatory inspections and escalations across the region.
- Monitor changes in medical device regulations and proactively translate regulatory developments into business impact assessments, compliance actions and market-entry timelines.
- Own and continuously improve the regional Quality Management System (QMS), ensuring alignment with ISO 13485 and applicable local regulatory requirements, including SOPs, document control, change control and CAPA.
- Lead regulatory, notified body, internal, supplier and distributor audits, maintaining inspection readiness and ensuring effective and timely closure of findings and corrective actions.
- Oversee post-market activities including complaint handling, post-market surveillance, vigilance reporting, field actions, labelling and IFU compliance, ensuring appropriate escalation of product and patient-safety risks.
- Manage regional supplier quality governance, including supplier qualification, risk assessments, audit programmes, performance monitoring and corrective action management.
- Build, mentor and manage a regional team of RA/QA specialists, setting priorities, developing technical capability, managing performance and supporting succession and resource planning.
- Partner with Commercial, R&D, Quality, Supply Chain, Operations and Global RA/QA leadership to support new product launches, portfolio expansion, distributor changes, M&A activities and wider business growth initiatives.
We are currently looking for candidates in Singapore
If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony ([Confidential Information]).
If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/
**PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role. **
