Dy. Manager/ Manager - RA

Job Description:

Position:        Dy. Manager/Manager - RA

Location:       Daman

Experience:   10 - 15 Years

Industries:     Pharma 

Responsibilities:       

• Regulatory Compliance:
• 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.