Sr. Officer/ Executive - RA
Quality HR Services
- Daman & Diu
- Permanent
- Full-time
- Maintaining compliance with ISO 13485, MDD, and MDR requirements.
- Preparing technical and device master files
- Preparing and compiling documents for registration to various countries
- Reviewing and updating of documents w.r.t various regulatory requirements
- Reviewing and updating of documents w.r.t various applicable standards
- Artwork approvals
- Risk management, clinical evaluation, and PMS for class Is, II and class III products
- Design and development support for regulatory, customer inputs, product specifications,verifications and validations
- Leading Regulatory, Customer and Certification audits
- CAPA management
- Coordination with marketing, development, purchase, QC and stores on day-to-day basis for requirements and support.
- Training to sub-ordinates on GMP, GDP, QMS
- Co-ordinating with local FDA and CDSCO for various permissions.
- Profound knowledge of ISO 13485, ISO 9001, ISO 14001 and Technical Documentation of Medical Device.
- Good Understanding of regulations, guidelines, procedures, and policies relating to development, registration and manufacturing of drug-device to expedite the submission, review and approval of global applications.