Regulatory Affair Specialist

Responsibilities

• Manage product registrations, renewals, variations, and lifecycle activities across Singapore, Thailand, Malaysia, and Taiwan.
• Support Quality Management System (QMS) maintenance, including SOPs, document control, change control, and CAPA.
• Ensure compliance with local medical device regulations, ISO 13485, and regional regulatory requirements.
• Support internal audits, audit readiness, supplier quality, and quality system improvements.
• Review product labeling, IFUs, complaint handling, post-market surveillance (PMS), and vigilance activities.
• Collaborate with regional cross-functional teams to support regulatory submissions, quality initiatives, and business objectives.
• 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 Sruthi Srikanth (careers@pes-international.com).
• 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/

Additional Information

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 Specialist to join us on a permanent role to help us deliver various projects in the Life Sciences Industry.

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