Regulatory Affairs Specialist IVD


Company:	Hays Specialist Recruitment
Salary:	£30 to £35 an hour
Hours:	Full-time
Location:	Cambridge, RG1 1NF
Working pattern:	Remote
Job type:	Contract
Posting date:	29 Oct 2026
Closing date:	28 Nov 2026

Apply for this job

Summary

Your new company

An exciting opportunity has arisen for an experienced Regulatory Affairs Specialist to join a leading global organisation within the life sciences and diagnostics sector. This role sits within a specialist Regulatory Affairs team supporting a diverse portfolio of clinical microbiology and in-vitro diagnostic (IVD) products.This is an excellent opportunity for a regulatory professional with strong technical documentation experience to contribute to high-impact projects within a highly regulated and innovative environment.

Your new role

As a Regulatory Affairs Specialist, you will be responsible for the creation, maintenance, and continuous improvement of regulatory technical documentation supporting a range of clinical microbiology and IVD products throughout their life cycle.Working within a collaborative global Regulatory Affairs team, you will support product registrations, regulatory submissions, post-market compliance activities, and documentation updates while partnering with cross-functional stakeholders across Regulatory Affairs, Quality, Technical Operations, and Product Management.Key Responsibilities

Develop, review, and maintain regulatory technical documentation and product technical files.

Create and update Instructions for Use (IFUs) and other supporting regulatory documentation.

Support regulatory submissions and product registrations across global markets.

Ensure documentation remains compliant with applicable regulatory requirements and quality standards.

Coordinate updates throughout the product lifecycle, from new product introduction through to post-market maintenance.

Collaborate with cross-functional teams to gather and interpret technical and scientific information.

Support documentation improvement and digital transformation initiatives.

Manage translation activities for customer-facing regulatory documents across multiple international markets.

Assist with regulatory compliance activities to maintain existing product approvals and facilitate new product launches.

What you'll need to succeed

Bachelor's degree, or equivalent, in Microbiology, Biological Sciences, or a related discipline, or equivalent laboratory-based industry experience.

Previous experience within Regulatory Affairs, ideally supporting IVD, diagnostics, medical devices, or clinical microbiology products.

Understanding of in vitro diagnostic products and their regulatory requirements.

Knowledge of relevant regulations including IVDR, MDR, FDA, and other international regulatory frameworks.

Experience preparing and maintaining regulatory documentation and technical files.

Strong technical writing and document management skills.

Proficient with Microsoft Office applications, including Word, Excel, and PowerPoint.

Excellent organisational, analytical, and problem-solving abilities.

Strong communication skills with the ability to work effectively across international and cross-functional teams.

Able to manage multiple priorities and meet deadlines within a fast-paced environment.

What you'll get in return

Opportunity to work with a globally recognised life sciences organisation.

Flexible remote/hybrid working arrangement.

Exposure to international regulatory projects and global product portfolios.

Collaborative and innovative working environment.

Competitive contract rate and potential for extension.

What you need to do now

If you are a Regulatory Affairs professional with experience in technical documentation, regulatory submissions, and IVD or microbiology products, we'd love to hear from you. Apply today to discuss this opportunity in confidence with one of our specialist recruitment consultants.

Apply for this job