- Document and review the company's Quality Manual and coordinate approval with the Partner, ensuring alignment with the Quality Policy, MDR 2017, and ISO 13485 systems.
- Establish and maintain the Quality Management System (QMS) across all levels of the organization.
- Review technical content of packaging material for all products.
- Maintain hard copies of original certificates and licenses, and organize other regulatory files.
- Maintain and update regulatory affairs (RA) status trackers.
- Lead global regulatory registration activities, with a primary focus on UKMDR (UK Medical Device Regulations) and EU MDR file preparation and submission.
- Prepare, submit, and review technical documentation (Technical Files/Design Dossiers) for international product registrations, including UKCA and CE marking submissions.
- Prepare, update, and review the Technical Master File (TMF) for current products.
- Prepare and review Technical Change Notifications to regulatory authorities and Notified Bodies.
- Review and respond to applications/queries related to DCGI (GMP, Manufacturing license), State FDA, Local FDA, and Central FDA (CDSCO).
- Track, procure,



and communicate regulatory and statutory guidelines, and applicable harmonized international standards for medical devices.
- Conduct and monitor internal audits as required by the QMS.
- Act as the key point of contact and represent the organization during external/third-party audits (Notified Body, MHRA, and other regulatory inspections), including audit preparation, live audit facing, and closure of findings/CAPAs.
- Maintain the Inward/Outward Register for documents received or sent by the Regulatory department; review international and national standards.
- Update Management on QMS functioning during Management Review Meetings (MRM).
- Support implementation of MDR 2017 and ISO 13485 requirements within the function.
- Provide leadership and guidance to subordinates within the department.
- Drive continuous improvement in the implementation, maintenance, and administration of the quality management

Pay: ₹400,000.00 - ₹600,000.00 per year

Benefits:

- Adaptable schedule
- Food provided
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Executive (Surat)
🏢 Elevate Scientific
📍 Surat