Officer/ Executive

4 days ago

Dadra, India Ami Polymer Pvt. Ltd Full time

1)Preparation of Quality Manual as per updated ISO 13485:2016 and ISO 9001:2015 2) Review and update change controls related to NPD Projects (New Product Development) and other required change 3) Preparation of Dossiers for Semi-Regulated market and Non-Regulated market according to CTD format and ACTD. 4) Prepare Site master file and device master file as per Indian MDR. 5) Preparation of Clinical evaluation report (CER), Risk management analysis, Review and update Essential requirement report (ESR). 6) Maintaining the CDSCO portal for Product registration, filling document submission, and license 7) Preparing new product marketing submission for FDA i.e. 510K and Premarket Approval (PMA). 8) Preparation of documents for brand registration a local FDA. Also having an Exposure and Compliance of EUMDR. 9) Preparation of dossier for medical devices, Risk Management documents as per ISO 14971:2012 (Risk Management plan, Risk Management Assessment, FMEA, and Risk Management Report). 10) Handling of Market Customer Complaints & Preparation and verifications of Tender Documents (Quality Section). 11) Good understanding of medical device standards, guidelines and regulations 11.1) Quality Management System (ISO 13485). 11.2) Risk Management System (ISO 14971). 11.3) Medical Device Regulation (EU MDR). 11.4) Food and Drug Association (US FDA 21 CFR part 820.30) 12) Responsible for ISO 13485 audit, CDSCO approved private bodies audit for Class A & Class B Medical products & CDSCO audit for Class C products. 13) Responsible for obtaining regulatory certifications such as non-conviction Certificate, Market Standing Certificate & Free Sale certificate. 14) Preparing the Technical Literature of any New Product development (Predicate and Innovator Devices) 15) Up to date on All the regulatory rule, norms, guidelines & clause changes across the globe w.r.t Ami Polymer Medical devices in CDSCO portal or other country "Sealing Expert.in Silicone 16) Responsible for Product/Device Listing & monitoring on daily basis in Global platforms (Regulatory market) - US, EU, UAE, ROW etc. 17) Preparation of SOP as per updated Standards and regulatory requirements. 18) Knowledge about Product validation and Testing of the new and existing products. Key Skills: Working experience in Pharmaceutical or Medical devices, knowledge about Testing evaluation and validation of the products, Knowledge about regulatory guidelines like ISO, USFDA, EUMDR, IMDR, Experience about the regulatory product certification and licensing in domestic and Export, Draft Testing protocols and Reports, Knowledge about technical literature search. Pay: ₹250,000.00 - ₹350,000.00 per year **Benefits**: - Flexible schedule - Food provided - Health insurance - Leave encashment - Paid sick time - Provident Fund Schedule: - Day shift Supplemental Pay: - Yearly bonus Work Location: In person

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