Regulatory Operations Specialist

Regulatory Operations Specialist

Location: Bracknell (Jealott's Hill) Hybrid (2-3 times per week on site)
Rate: £23 per hour
Contract: 6-month and 12-month contracts available

Overview

We are recruiting for a Regulatory Operations Specialist to join a high-performing team supporting new product and solution development within a regulated environment. This role will play a key part in ensuring compliance with global regulatory standards and supporting successful product submissions.

Key Responsibilities

Support cross-functional development teams by advising on regulatory requirements, standards, and strategy
Plan, prepare, and coordinate regulatory submissions, ensuring all documentation is accurate and compliant
Review development quality documentation to ensure readiness for submission
Coordinate testing activities required to support regulatory approvals
Review and approve product labelling and marketing materials in line with regulatory requirements
Maintain existing regulatory filings and licences, including managing updates and change control processes
Support regulatory planning for new product introductions and product changes, including CE marking and risk assessments
Work closely with product and project teams to align regulatory strategy with commercial objectivesRequirements

Experience within Regulatory Affairs in a regulated industry (e.g. medical devices, pharmaceuticals, or life sciences)
Strong understanding of regulatory submissions and compliance processes
Experience with product labelling, marketing review, and regulatory documentation
Ability to work cross-functionally and manage multiple stakeholdersQualifications

Degree (or equivalent experience) in Regulatory Affairs, Life Sciences, or a related discipline
Demonstrated experience through academic training and/or industry exposure in regulatory environmentsAdditional Information

Immediate start available
Opportunity to work on innovative product development programmes
Flexible contract lengths (6 or 12 months availble)

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Only candidates based in UK and eligible to work in UK are allowed