3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Responsibilities Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations.? Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation.? Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements.? Devel...

Posted 2 weeks ago

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Assistant Manager - Quality Compliance Zentiva

6.0 - 8.0 years

0 Lacs

ankleshwar, gujrat, india

Remote

Job Title: Assistant Manager - Quality Compliance (Supplier Quality Assurance) Department: Quality Compliance Reports to: Quality Compliance Manager Location: Ankleshwar Position Type: Full-time Qualifications And Experience Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field. Experience: Minimum 68 years of experience in Quality Assurance / Quality Compliance within the pharmaceutical industry, with at least 2 years in a Supplier Quality Assurance role. Preferred: Exposure to regulatory inspections (e.g., USFDA, MHRA, TGA), and experience in working with global suppliers. Job Purpose To lead and manage Supplier Quality Assurance (SQA) activities ensuring all th...

Posted 2 months ago

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