Manager -Regulatory Affairs (Medical Device)

Job Description

Hi, Currently we required Manager - Regulatory Affairs, for leading Medical device company. location - Sohna, Nuh, Haryana exp - Minimum 6+ years 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.Job Description Position: - Has work experience of 5+ years in the regulatory domain within the Medical Device industry - Has expertise with drafting, reviewing and submission of Regulatory filings and Query responses in EU markets for obtaining CE marking in line with the latest EU Medical Device Regulation - Regulatory knowledge of filing medical device applications in US and Canada will be an advantage - Possesses good knowledge of ISO 13485 and ISO 14971 - Holds experience in ensuring compliance Regulatory lifecycle management of medical devices by coordination with internal stakeholders and regulatory agencies - Assisting in the preparation of technical presentations/ meetings with Regulatory Consultants An opportunity to work as a part of the Medical Affairs function for one of the fast growing organisations in the industry. Regards, Khushi Asthana HR Manager Pratham Search Job Types: Full-time, Permanent Pay: ₹60,000.00 - ₹80,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Fixed shift Morning shift Work Location: In person