Manager - QA/RA

1 week ago


India Gurgaon Gurugram Michael Page Full time
  • Play a pivotal role in ensuring the quality and regulatory compliance of medic
  • Contribute to the organization's success by effectively managing QA/RA process
Job Description

Reporting to the Country Head, you will:

  • Spearhead the preparation, review, submission, and follow-up of dossiers for product registration with the CDSCO in India.
  • Proactively plan and manage product registration, post-approvals, and renewals with EU and US manufacturers, keeping them informed about Indian Medical Device Rules.
  • Develop strategies to ensure regulatory compliance, including pre-submission planning, clarification of potential regulatory pathways, and follow-up of submissions under review.
  • Provide regulatory guidance and support to cross-functional teams.
  • Serve as the liaison with Indian Regulatory Authorities, maintaining open communication channels.
  • Stay abreast of new developments in QA/RA, including standards and regulations, assess their impact, and implement necessary mitigating actions.
  • Facilitate both internal and external quality audits.
  • Manage documentation control, improvement processes, non-conformance actions, corrective and preventive actions, product complaint handling, and field actions.
The Successful Applicant

In order to apply successfully to this role, you will have:

  • Master's or bachelor's degree in engineering, technical, or science field from a recognised university.
  • Lead Auditor Certification for ISO 9001:2015 is desirable.
  • An in-depth understanding of a Quality Management System (QMS) and requirements for ISO, MDR, and other relevant regulations.
  • 5+ years of experience in a managerial capacity within the QA/RA function in a health-care company.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
  • Strong analytic and problem-solving skills, with the ability to identify and resolve regulatory issues.
  • Ability to work independently managing multiple projects simultaneously.
What's on Offer
  • A dynamic and collaborative work environment with a team of experienced professionals.
  • Competitive compensation and benefits package.

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