Sr. Executive - RA

Job Description:

Position:         Sr. Executive - RA

Location:        Daman

Experience:     8 to 12 Years

Industries:      Pharma

Responsibilities:

• 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.

Required Skills:

• 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.

Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc

Salary :- Upto 8.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-