CY Partners Scientific Recruitment - Regulatory Affairs Officer (permanent, Newcastle, IVDr)

Bionow; Newcastle upon Tyne; On-site; GBP 80,000 - 100,000; Full time

Job description

CY Partners Scientific Recruitment - Regulatory Affairs Officer (permanent, Newcastle, IVDr)

Job Title: Regulatory Affairs Officer (permanent, Newcastle, IVDr)

Category: Technical roles

Closing Date: 18/04/2025

CY Partners Recruitment is delighted to be partnering with a growing Biotechnology company based in Newcastle with their search for a Regulatory Affairs Officer.

Reporting to the QARA Manager in this key role, you will ensure compliance with quality standards, regulatory requirements, and best practices within the organisation.

This is an exceptional role for someone who is looking to take a step into a dynamic environment, with projected significant growth for the organisation and the post-holder.

Main Duties and Responsibilities

1. Regulatory Submissions - compile and submit regulatory documentation to relevant agencies for product registration and license renewals.
2. Compliance Monitoring - stay updated on current regulations and guidelines ensuring company practices adhere to them and identifying potential compliance risks.
3. Vigilance Reporting – report vigilance events to competent authorities.
4. Communication with Agencies - communicate with regulatory agencies, responding to queries and addressing concerns.
5. Internal Consultation - provide regulatory advice to cross-functional teams (R&D, manufacturing, marketing) on product development, labelling, and market access strategies.
6. Documentation Management - maintain accurate and organised regulatory documentation, including records of submissions, correspondence with agencies, and product information.
7. Risk Assessment - identify and assess potential regulatory risks associated with new products or changes to existing products.
8. Post-Market Surveillance - monitor product performance post-approval, reporting any safety concerns to regulatory agencies.

To be considered for the role of RA Officer, you’ll need the following qualifications, skills, and experience:

• Bachelor’s degree or equivalent experience in a Life Science subject.
• Strong understanding of ISO 13485:2016, MHRA, and IVDR regulatory frameworks.
• Experience in regulatory affairs within the medical device industry.
• Excellent attention to detail regarding existing and new documentation.
• Experience or knowledge of IVD medical devices and Quality Systems.
• Positive, team-focused approach to working and problem-solving.
• Competent with Microsoft Word, Excel, PowerPoint, and SharePoint.

Location – The role is permanent and to be primarily based at the site in Newcastle upon Tyne.

CY Partners is acting as an Employment Business / Agency in relation to this vacancy.