Medical Device Regulatory Specialist

4 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Affairs Expert

Job Description:

We are seeking an experienced Regulatory Affairs professional with expertise in pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring adherence to applicable regulations.

  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies to support new product development and lifecycle management.
  • Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.

Key Skills and Qualifications:

To be successful in this role, you will need:

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Expertise in pharmaceutical and medical device regulatory compliance.
  • Excellent communication and problem-solving skills.
  • Ability to work independently and as part of a team.

Benefits:

This role offers:

  • A competitive compensation package.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.

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