Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Hemant Surgical Industries Limited

7.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Job Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 712+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to BIS (Bureau of Indian Standards) inspections, compliance, product registrations, and application filings for medical devices. The role also includes handling CDSCO (Central Drugs Standard Control Organization) online submissions, licensing, and regulatory documentation to ensure full compliance with applicable Indian medical device regulatory...

Posted 1 month ago

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Regulatory Affairs Manager Rxcruit

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 1 month 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 2 months ago

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