Regulatory Affairs Associate

Description:

A globally recognized leader in tissue-healing technologies is seeking a Regulatory Affairs Associate to join its expanding team in Plymouth. With operations across Europe, Asia, and Israel, this company manufactures advanced surgical products, including tissue adhesives, sutures, haemostats, sealants, fixation devices, and more. Since 2019, the company has acquired seven specialized businesses and now operates multiple R&D hubs in the UK, Ireland, Germany, France, and Israel.

As a Regulatory Affairs Associate, you will support new product development and manage regulatory submissions for various global markets, ensuring compliance with relevant medical device regulations. You will play a key role in maintaining approvals, supporting audits, vigilance activities, and post-market surveillance, contributing directly to the safety and quality of life-enhancing products.

Key Responsibilities:

• Generate and submit high-quality, compliant documentation for all product classes across Europe, the USA, and other international markets

• Maintain up-to-date registrations, certifications, and regulatory submissions

• Support new product development and major line extensions, ensuring all RA activities are properly integrated

• Develop regulatory strategies and participate in project planning

• Review and approve documentation such as design controls, labeling, and marketing literature

• Submit updates related to product, process, and QMS changes to global authorities

• Act as SME for audits and inspection preparation (FDA, Notified Bodies, etc.)

• Support and perform post-market surveillance, incident reporting, and recall procedures

• Monitor regulatory changes and contribute to continuous improvement efforts

• Promote company values: Care, Fair, Dare, and uphold health & safety policies

Required Skills and Attributes:

• Degree in a science-related field or equivalent experience in the medical devices industry

• Regulatory experience and working knowledge of EU MDR, US FDA regulations, and CFR Part 820 desirable

• Familiarity with global pre-market approval processes

• Excellent written and verbal communication skills

• Strong organizational, team collaboration, and analytical abilities

• Skilled in preparing and managing regulatory documents using IT tools

• Confidence to challenge and influence for process improvements

Salary:
£35,000 – £40,000 per annum
(£2916 – £3333 monthly)