Regulatory Affair Officer

Pune

Job description

 
Experience: 2 – 5 years
Salary: ₹ 4,00,000 – 6,00,000 P.A.
 
Roles and Responsibilities
  1. To prepare and manage technical files/dossiers for products with regulatory agencies (FDA510K, CDSCO).
  2. 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.
  3. Coordinate and manage QMS and product audits (internal and external).
  4. 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.
Qualifications
  • 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.
Key Points
  • Head – Regulatory Affairs
  • IT Services & Consulting
  • Legal & Regulatory
  • Full Time, Permanent
  • Corporate Affairs
Education
  • Graduation Not Required
Key Skills
  • FDA
  • ISO 13485
  • QMS Implementation
  • Post-market surveillance
  • Product audit

Application Form

Mail your resume to hr@alveo.fit