Regulatory Affairs Associate - Medical Devices

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 devices

Key Responsibilities

• Generation and submission of high quality regulatory compliant documentation for all classes of product in Europe, USA and other global markets to ensure pre-market approvals are achieved in a timely manner.
• Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations in Europe, USA and other global markets.
• Maintain Regulatory Technical Documentation.
• Act as a core team member for new product developments and major extensions to existing product lines, ensuring all RA activities are included in the project plan.
• Supporting the development of new product Regulatory Strategy documents.
• Responsible for regulatory review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, change controls.
• 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.
• Act as regulatory technical documentation Subject Matter Expert for the preparation, participation and facilitating in responses to audits by customers, FDA, Notified Bodies and other global health authorities.
• Participate in company quality system audits.
• Monitor relevant industry-wide regulatory affairs activities
• Continuous improvement and development of the generation and maintenance processes of regulatory documentation.
• Perform post market surveillance activities to support reports on the status of such activities of a periodic basis such as vigilance reporting, customer feedback, post market clinical trends and pro-active market feedback.
• Preparation and approval of Incident Reporting and FSCA/Recall reporting to meet regulatory requirements worldwide.
• Promote the Care, Fair, Dare company values in the workplace.
• Promote the Health and Safety policies in the workplace

Your Skills and Attributes

• Science based degree or equivalent plus relevant experience of working in the medical device arena, preferably in a regulatory role.
• Working knowledge of regulatory requirements is desirable.
• Ideally has experience in key market approval requirements within Europe and USA.
• Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.
• Good organisational skills, including efficiency, responsiveness, and collaboration in a team environment.
• Ability to work under pressure to meet process/project time frames, regulatory requirements, and company requirements.
• Strong analytical skills.
• The ability to influence and challenge others in a constructive way to deliver improvements.
• Competent IT skill in preparing regulatory documentation, files, and logs.

Salary

35,000 - 40,000 per annum

How to Apply

Apply now by submitting your CV below, alternatively you can send your CV to (url removed). Please include "Regulatory Affairs Associate" in the subject line