Regulatory Affairs Associate

Role overview

We are looking for a Regulatory Operations Specialist to support product and solution development within a tightly regulated environment. The role is focused on helping ensure compliance with international regulatory requirements and contributing to the success of product submissions.

Location and contract

• Bracknell (Jealott’s Hill)
• Hybrid working pattern with on-site presence expected 2 to 3 times per week
• Pay rate: £23 per hour
• Temporary contract options available for 6 months or 12 months

Key responsibilities

• Support cross-functional development teams with guidance on regulatory standards, expectations, and strategy.
• Plan, prepare, and coordinate regulatory submissions, making sure all documents are complete, accurate, and compliant.
• Review development quality documentation to confirm it is ready for submission.
• Coordinate testing activities needed to support regulatory approvals.
• Assess and approve product labels and marketing content to ensure they meet regulatory requirements.
• Maintain existing regulatory filings and licences, including updates and change-control activities.
• Assist with regulatory planning for new product launches and product modifications, including CE marking and risk assessment work.
• Work closely with product and project teams to align regulatory direction with business goals.

Requirements

• Previous experience in Regulatory Affairs within a regulated sector such as medical devices, pharmaceuticals, or life sciences.
• Good knowledge of regulatory submissions and compliance procedures.
• Experience reviewing product labelling, marketing materials, and regulatory documentation.
• Ability to collaborate across functions and manage several stakeholders at once.
• A degree in Regulatory Affairs, Life Sciences, or a related field, or equivalent practical experience.
• Exposure to regulated environments through academic training and/or industry experience.

Additional information

• Immediate start available.
• Opportunity to contribute to innovative product development programmes.
• Flexible contract lengths of 6 or 12 months.