Job Title: Regulatory Affairs Associate
Industry: Medical Devices
Location: Plymouth
Position Type: Permanent
About The Company
A world-leading developer and manufacturer of tissue-healing technology, this company focuses on quality patient outcomes and value for payers. Its surgical products include tissue adhesives, sutures, haemostats, fixation devices, and sealants. Since 2019, it has acquired seven companies specialising in internal sealants, biomaterials, wound care, and surgical implants. Products are manufactured across Europe, Asia, and Israel, with global distribution through partners and direct sales teams. The company operates R&D hubs in the UK, Ireland, Germany, France, and Israel and employs over 1,500 people.
Job Description
Overview
Support new product developments and creation of their submissions in Europe, USA and other global markets in compliance with regulatory requirements.
Maintenance of regulatory approvals inclusive of associated technical regulatory documentation in accordance with The Medical Devices Regulations 2002, Medical Device Regulation [EU] 2017/745, CFR Part 820 and other global markets.
Assessment of and submission to regulatory authorities in Europe, USA and other global markets for changes to devices, manufacture processes and the quality management system.
Perform post-market and vigilance activities in support of globally marketed devicesKey Responsibilities
Generation and submission of high quality regu...