Manager - QA/RA

1 month ago

gurugram, India 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

About Our Client

Our client is a leading manufacturer of medical devices, committed to providing high-quality products to patients worldwide. The organisation is looking to expand its presence in India, and they're looking for a skilled QA/RA Specialist to drive regulatory excellence.

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.

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