10.0 - 12.0 years

0 Lacs

india

On-site

Job Profile: Regulatory Affairs Manager Experience: 10+ years Location: Delhi NCR Industry: Medical Device/ Pharma Job Description: Regulatory Affairs & Quality Compliance (MDR 2017) End-to-end management of regulatory dossiers, licensing, renewals, labeling compliance, and post-market surveillance. Cross-Functional Coordination Ensures product lifecycle compliance, including change control and audit readiness. Issue & Risk Management Leads regulatory audits, manages non-compliance, and drives quick resolution of critical issues. Government Liaison Strong engagement with regulatory authorities, ministries, NPPA, CPCB, DOP, BIS, and Materiovigilance. Policy & Advocacy Tracks regulatory develo...

Posted 23 hours ago

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Sr. Manager Quality Assurance Illusion Dental Laboratory

0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

The Senior Manager QMS will lead the development, implementation, maintenance, and continuous improvement of the company's ISO 13485-compliant Quality Management System across multiple manufacturing and support units. This role is critical to ensure consistent product quality, process efficiency, global regulatory compliance readiness, and a strong quality culture across the organization. Key Responsibilities: QMS Governance & Compliance Lead the organization-wide implementation and maintenance of ISO 13485:2016 , 21 CFR Part 820 , Schedule V MDR 2017 , and MDSAP -aligned QMS. Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times. Conduct and...

Posted 1 week ago

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