Job
Description
URGENT OPENING Currently We required Manager - regulatory Affairs for Medical Device company. JD-Manager- Regulatory Affairs Plant office - Medical devices 52-54,63&64, Roz ka meo , Industrial Area, Nuh , District. Mewat ( Haryana), India Company will provide you the cab facility from Fix point of Gurugram & Faridabad Working Daya - 6 days in a week The candidate Profile and the job description is as follows - · The Company has state of art manufacturing facility and its own R & D facility with 10,000 and 1,00,000 Class room specifications with continuous innovations and thereby offering customized products as per the requirements of various markets in India and abroad. · The Company is accredited with the following standards – a) ISO 9001 : 2008 b) ISO 13485 : 2003 ( EN) c) Directive 93/42/EEC (CE) d) Registration certificate with Dept of Health & Human Services, USA e) GMP Certificate as per schedule M. f) DGQA registered · The Company is having strong presence in almost all the Corporate Hospitals across India besides Trade, Military, Para-Military forces and in prestigious Government institutions. · The Company markets under its own brand name in International markets like UAE, Oman, Sri Lanka, Nepal and Bangladesh and besides being an OEM supplier to various MNCs for the entire Europe, Australia, New Zealand, South Africa etc. · Company’s product range includes various types of high quality gauze and bandage products besides some unique products in the Advance Wound Care segment which are being exported to major companies in Europe as well as to Australia, New Zealand, Middle & Far East and South Africa. Key responsibilities: Spearheaded regulatory submission strategy for CE marking under EU MDR for Class IIa, IIb & III devices. Authored and maintained FDA 510 (K) submission, including predicate device comparison and labeling review. Developed and maintained Technical Files and Design Dossier for European markets. Coordinated Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR). Acted as point-of-contact for notified bodies and regulatory authorities during audits and inspections. Implemented and maintained ISO 13485:2016-Compliant QMS, prepared company for successful MDSAP audit. Developed and maintained company-wide QMS in compliance with ISO 13485:2016 AND 21 CFR 820. Conducted risk management activities as per ISO 14971:2019 and ISO/TR 24971:2020, including, AFAP, FMEA and Hazard Analysis. Led PMS activity (Plan, Report and arrange the feedback, sales data and other regulatory requirements from Marketing team). Prepare documents related to the Post Market Surveillance, General Safety and Performance Requirement (GSPR) Risk Management process of Class III medical devices as per MDR 2017. Plz Mention your Current CTC - Expected CTC - Notice period- Date of Birth- And ready for relocate - Regards, Khushi Asthana HR Manager Pratham Search Job Types: Full-time, Permanent Pay: ₹70,000.00 - ₹100,000.00 per month Benefits: Cell phone reimbursement Food provided Health insurance Provident Fund Work Location: In person
