Understand and ensure compliance with global regulatory requirements for medical devices, including FDA and EU regulations.
Audits:
Conduct internal and external audits to assess compliance and identify areas for improvement.
Regulatory Submissions:
Prepare and submit regulatory documentation for various markets, including CE marking and FDA clearance.
Post-Market Surveillance:
Monitor product performance and safety in the market and take appropriate action.
Risk Management:
Implement and maintain risk management systems, identifying and mitigating potential risks associated with medical devices.
Documentation and Record Keeping:
Maintain accurate records of quality and regulatory activities.
Other QA responsibilities include.
Manage several processes as process owner.
Organize and perform internal audits and manage external audits and inspections.
Coordinate monitoring and data analysis activities.
Coordinate CAPA activities.
Review complaint and nonconformity reports
Identify regulatory requirements.
Develop and review the regulatory strategy.
Provide input/support to the development and clinical evaluation teams.
Ensure compliance and compose/review regulatory files (e.g. technical documentation, 510(k).
Manage regulatory submissions, registrations and notifications o Manage vigilance activities.
Required Skills:
Good Verbal & Written Communication
Leadership Qualities
Positive Attitude towards responsibility.
Required Qualification: - M.PharmSalary :- Upto 10.00 LPAIf 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 :-