Regulatory Affairs Associate

Note: Qualification:

(Pharma background (B. Pharma / M. Pharma) profiles will not be considered)

Mandatory Skills:

• Regulatory Affairs Medical Devices

• EU MDR compliance

• Design History File (DHF)

• Risk Assessment & Risk Management

• Familiarity with ISO 13485 and other applicable standards

Key Responsibilities:

• Prepare, review, and manage regulatory submissions for medical devices (India and international markets)
  
• Ensure compliance with

  EU MDR (Medical Device Regulation)

  and local regulatory requirements
• Maintain and update

  Design History Files (DHF)

  , Technical Files, and Risk Management documentation
• Conduct

  risk assessments

  and support implementation of risk mitigation strategies
• Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance
  
• Monitor changes in medical device regulations and assess their impact on company products
  
• Interface with regulatory bodies for product approvals and audits