Regulatory Affairs Specialist

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.

Key Attributes / Responsibilities

• Lead and support regulatory submissions for medical devices (Class I, II, and III) to Indian regulatory authorities (CDSCO and related bodies).
• Prepare, review, and manage complete submission dossiers in compliance with Indian Medical Device Rules (MDR) and applicable guidelines.
• Act as the primary point of contact with Health Authorities (HA), including responding to queries, deficiency letters, and requests for additional information in a timely and effective manner.
• Develop and provide regulatory strategy and guidance for product registration, approvals, renewals, variations, and lifecycle management in India.
• Interpret and apply current Indian regulatory requirements, standards, and guidance documents to ensure ongoing compliance.
• Support cross-functional teams (R&D, Quality, Manufacturing, and Commercial) with regulatory input across the product lifecycle.
• Monitor changes in Indian medical device regulations and proactively assess impact on existing and pipeline products.
• Maintain accurate regulatory documentation and ensure audit readiness.

We are currently looking for candidates in India

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 :