Regulatory Affairs Associate

• 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

Overvie

wWe 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 Responsibiliti

• esSupport cross-functional development teams by advising on regulatory requirements, standards, and strate
• gyPlan, prepare, and coordinate regulatory submissions, ensuring all documentation is accurate and complia
• ntReview development quality documentation to ensure readiness for submissi
• onCoordinate testing activities required to support regulatory approva
• lsReview and approve product labelling and marketing materials in line with regulatory requiremen
• tsMaintain existing regulatory filings and licences, including managing updates and change control process
• esSupport regulatory planning for new product introductions and product changes, including CE marking and risk assessmen
• tsWork closely with product and project teams to align regulatory strategy with commercial objectiv

esRequireme

• ntsExperience within Regulatory Affairs in a regulated industry (e.g. medical devices, pharmaceuticals, or life scienc
• es)Strong understanding of regulatory submissions and compliance proces
• sesExperience with product labelling, marketing review, and regulatory documentat
• ionAbility to work cross-functionally and manage multiple stakehold

ersQualificat

• ionsDegree (or equivalent experience) in Regulatory Affairs, Life Sciences, or a related discip
• lineDemonstrated experience through academic training and/or industry exposure in regulatory environm

entsAdditional Inform

• ationImmediate start avai
• lableOpportunity to work on innovative product development progr
• ammesFlexible contract lengths (6 o

r 12)…