Location
Gurgaon | India
Job description
- 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.
Job tags
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