Quality Assurance, Regulatory Affairs Manager

  Regulatory Affairs

Job title: Quality Assurance, Regulatory Affairs Manager

Company: Antal International

Job description: Job Description Designation: Quality Assurance,Regulatory Affairs Manager Location: Bengaluru, Karnataka Industry: Medical Device Experience: 3+ years in class II & III Medical Device Reports To: GM – Manufacturing About the company: Client with a

Job Description Designation: Quality Assurance,Regulatory Affairs Manager Location: Bengaluru, Karnataka Industry: Medical Device Experience: 3+ years in class II & III Medical Device Reports To: GM – Manufacturing About the company: Client with a decade of core expertise in manufacturing of X ray equipment’s, has expanded its capabilities – single detector solutions, dual detector solutions, floor mounted systems, ceiling suspended systems, floor to ceiling systems, mobile system, line powered and Battery operated systems and a bevy of ranges in C arm’s . KEY RESPONSIBILITIES: Responsible for Establishment and Implementation of QMS as per ISO 9001, ISO 13485, CE , FDA etc. and other Regulatory approvals and working on Class II , III medical devices. In depth understanding of ISO 13485, CFR 820, EU MDR, CE & ISO 14971, GMP, preferred certified Internal Auditor. Responsible to get the registration of medical devices in India and other regulatory bodies. Experience in QMS, SOP, IQ, PQ, OQ, CE submissions, other global regulatory requirements. Responsible as Management Representative for conducting audits internally and externally with sub – contractors, MRM review on quality systems, processes, and products to ensure compliance with regulations. Developing regulatory strategies, preparing CE / US FDA submission, providing documentation for international submissions, evaluating proposed product changes for regulatory impact, and preparing necessary documentation. Assist in risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report. Review Design History Files and Technical Files for conformance to applicable regulatory requirements. Maintain Regulatory Affairs product files to support compliance with regulatory requirements and Approvals to introduce new and modified products to the market. Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications. Participate in the development of corrective & preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings. Keeps current on global directives, harmonized standards, procedures and communicates changes that may affect R&D and cross – functional team. REQUISITE SKILLS: Understanding of ISO 13485, CFR 820, EU MDR, CE & ISO 14971, GMP, preferred certified Internal Auditor. Knowledge in QMS, SOP, IQ, PQ, OQ, CE submissions, other global regulatory requirements. Team Building. Excellent communication skills. Strong organizational skills with a problem-solving attitude.

Expected salary:

Location: Bangalore, Karnataka

Job date: Mon, 29 Aug 2022 22:38:39 GMT

Apply for the job now!

LEAVE A COMMENT