Experience: 2 – 5 years
Salary: ₹ 4,00,000 – 6,00,000 P.A.
Roles and Responsibilities
- To prepare and manage technical files/dossiers for products with regulatory agencies (FDA510K, CDSCO).
- Take on the role of Management representative for the organization and manage ISO. 13485:2016 QMS by coordinating with internal and external cross-functional teams.
- Coordinate and manage QMS and product audits (internal and external).
- Managing post-market surveillance of products and coordinating reports to regulatory authorities as required.
Detailed Job Description
- Create and review documents used in design and development, monitor audits of various departments and quality control areas.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
- Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
- Manage non-conformance, corrective action preventive actions, and deviation.
- Develop and support the implementation of departmental and divisional policies and procedures.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product changes for compliance with applicable regulations.
- Participate with peers in the formulation of overall direction, processes, systems, and talent development for quality organizations.
- Manage and renew all the regulatory registrations.
- Mandatory: Experience with technical file preparation and filing with FDA510K or CE (IVDR/IVDD experience preferred).
- Mandatory: Experience in implementation and management of QMS (ISO 13485:2016). Candidates with ISO 13485 lead auditor certification will be preferred.
- 2 to 5 years of experience is preferred
- Knowledge of FDA medical device and drug regulations, guidance, and import/export requirements.
- Head – Regulatory Affairs
- IT Services & Consulting
- Legal & Regulatory
- Full Time, Permanent
- Corporate Affairs
- Graduation Not Required
- ISO 13485
- QMS Implementation
- Post-market surveillance
- Product audit
Mail your resume to firstname.lastname@example.org