Job Description

: Manager - Medical Devices

Location:

Pimpri Chinchwad, Pune

Experience:

2-8 Years

Salary:

As per industry standards and commensurate with experience

Contact:

91121 18881



We are seeking a dynamic and experienced professional for the position of

Manager- Medical Devices

, responsible for handling regulatory affairs, quality management systems, risk management, and post-market surveillance activities.

Regulatory Affairs

Prepare, compile and manage regulatory submissions, including FDA 510(k), CDSCO registration, CE Marking (EU MDR), SFDA, and UKCA.

Develop and maintain technical files, dossiers, registration documentation, and regulatory reports in accordance with applicable requirements. Coordinate responses to regulatory queries, address deficiencies, and manage follow-up communications with regulatory authorities. Conduct regulatory gap assessments and ensure ongoing compliance with current and evolving regulatory requirements.
Quality Management System (QMS)

Implement and maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and applicable national and international standards. Plan and conduct internal audits, and support external audits by regulatory bodies and certification agencies. Coordinate and support certification activities for ISO 13485, ISO 11135, ISO 11137, ISO 11737, and ISO 14971. Review SOPs and other quality system documentation to ensure adequacy, compliance, and effective implementation.
Design, Development & Risk Management

Review design and development documentation Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR). Lead risk management activities in accordance with ISO 14971 and related regulatory requirements.
Job Type: Full-time

Pay: ₹480,000.00 - ₹720,000.00 per year

Benefits:

Health insurance
Work Location: In person