The Regulatory Affairs (RA) Executive is responsible for supporting regulatory compliance activities for medical devices in accordance with ISO 13485, US FDA (21 CFR Part 820), and
EU MDR requirements. The role involves preparing and maintaining regulatory documentation, supporting product registrations and submissions, addressing regulatory queries, coordinating audits and inspections, and collaborating with cross-functional teams to ensure ongoing compliance. The incumbent will assist in implementing corrective and preventive actions (CAPA), maintaining regulatory records, and supporting the organization’s quality and regulatory objectives.
Key Responsibilities:
- Understand and implement the ISO 13485, 21 CFR 820 and EU MDR regulations requirements with respect to devices.
- Executive to maintain the documents and records are in compliance with USFDA regulations, ISO 13485 and EU MDR requirements.
- Prepare and update the documentation for ISO 13485, EU MDR and 510(k)
submission.
- Addressing notified bodies queries and USFDA queries.
- Provide support for regulatory inspections and audits related to USFDA, ISO 13485
and EU MDR.
- Maintain audit reports and documentation of USFDA Audit, ISO 13485 and EU MDR audit performed.
- Collaborate with respective Division’s QA Manager / QA Engineer / Division’s
RA/Clinical team and other stakeholders.
- Assist with RA Manager.
- Ensure CAPA (Corrective and Preventive Actions) are implemented and maintained in response to audit findings.
Experience: 1 – 3 years of skilled experience in Regulatory Affairs within the medical device or healthcare industry.
Skills: Problem solving, query addressing, Proficiency in MS Office tools, Ability to coordinate cross-functional teams, Effective communication skills.