EU MDR Specialist – 9 to 12 yrs- Pune

Short Description

EU MDR Specialist – 9 to 12 yrs- Pune

Qualifications

BE/B.tech, ME/M.tech,MCA

Job Responsibilities

Exp 8 to 10 years Role EU MDR Specialist Looking for a Senior Regulatory affairs specialist to support global medical device manufacturers with meeting the MDR requirements with a view to provide for a comprehensive MDR transition support This support will require the person to have expertise in medical device regulatory affairs and quality assurance with view to accomplish the following Perform a gap analysis of CE Technical Documentation and CE related processes and procedures in accordance to the MDR Based on the MDR IVDR strategy and prioritization help plan out a detailed remediation plan with milestones and responsibilities quality system management support and post market surveillance support and management Job description Understands the regulatory landscape and Supports the cross functional teams with regulatory guidance during the design control phases of a new product or product re engineering phases Responsible for the planning coordination and preparation of document packages for regulatory submission across different projects Responsible for implementation of EU MDR related deliverables across product lines Actively participating in GAP analysis between MDD and MDR thereby identifying gaps in the current devices Provides guidance on global compliance such as CE Marking and product registrations to extend possible Experience in managing Clinical Evaluations and writing updating Clinical Evaluation Reports CERs for EU MDR compliance will be added advantage Skills and experience Bachelor s degree in biomedical Engineering Regulatory affairs Biotechnology healthcare or equivalent Certified regulatory affairs professional would be desirable Minimum of 8to10 years of experience in the medical device industry leading regulatory affairs for a range of products globally Actively participating in GAP analysis between MDD and MDR thereby identifying gaps in the current devices CE marking procedural update Releasing new Technical file template for CE marking Medical Devices Clinical Evaluation procedure updates which is required to continue CE mark Medical devices Risk management procedure revision and implementation as per EN ISO 14971 Actively involved in the Technical file preparation of various Class 2 and 3 devices which will have to be MDR compliant by May26 2020 Preparing Post market Technical file and implementing post market requirement for MDR Must have experience with successful preparation of 510 k PMA or international documents for product approvals Strong understanding of Design Control processes including standards like ISO134852016 IEC 62304 ISO 14971 is must Excellent working knowledge of medical device regulations FDA 21 CFR MDD other global laws and regulations will be desirable

Ref:

362297

Posted on:

November 4, 2019

Experience level:

Experienced

Contract type:

Permanent

Location:

Pune

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