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 objectives

Requirements

• 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 stakeholders

Qualifications

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

Additional 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.