Regulatory Affairs Manager

6 days ago

Cambridge, United Kingdom Russell Taylor Group Ltd Full time

Regulatory Affairs Manager Location: CambridgeshireEmployment Type: (Full-time: Mon-Fri) (Hybrid: 2 - 3 days on site) We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities across a product portfolio and ensure the products remain safe, effective, and compliant for worldwide markets. This is an exciting opportunity for a proactive regulatory professional to shape regulatory strategy, influence product development, and play a key leadership role within the RA department. What you'll be doing Lead regulatory strategies and submissions for new and updated products. Act as the regulatory lead and SME for product development projects, providing solution-focused guidance. Review and approve technical documentation, risk management files, performance evaluation evidence and submission materials. Manage global registrations, regulatory submissions, and interactions with authorities, authorised representatives, distributors, and external partners. Oversee post-market surveillance, vigilance reporting, and safety officer responsibilities. Ensure regulatory compliance of product labelling, promotional materials, and commercial documentation. Maintain accurate regulatory records, documentation systems, and databases. Provide expert interpretation of global regulations and support conformity to evolving standards. Contribute to leadership, training, and development within the RA team. Act as the Person Responsible for Regulatory Compliance (PRRC) under EU IVDR. Essential Criteria Degree-level education or equivalent in a life science or related discipline. >5 years of experience in IVD and/or medical device regulation (preferably EU-related). Recognisable qualification in Regulatory Affairs (e.g., RAPS, TOPRA) and evidence of ongoing CPD. Strong experience working within an ISO 13485 Quality Management System. Ability to independently manage multiple projects, department initiatives, and day-to-day regulatory tasks. Desirable Criteria Expertise in IVD regulatory frameworks, including 21 CFR Part 820 (QSR/QMSR). Experience in post-market surveillance, vigilance, and product recall activities. Proven experience interacting with competent authorities, global regulators, and notified bodies. Why join us? High-impact strategic role with global regulatory responsibility Opportunity to influence product development and organisational compliance Supportive, collaborative working environment Competitive salary and benefits package Important Information We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us #J-18808-Ljbffr

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