Principal Regulatory Affairs Specialist, IVDR

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Direct the regulatory strategy, execution, and maintenance of IVDs in the UK market.

• Collaborate with regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and serve as an administrator for relevant databases including UK MHRA DORS and EUDAMED.

• Propose regulatory strategies for anticipated product modifications concerning UKCA and IVDR.

• Develop and uphold UKCA and IVDR Technical Documentation.

• Prepare regulatory submissions and notify the notified body and MHRA regarding any changes.

• Act as the RA lead for technical reviews by the notified body, surveillance reviews, and certificate renewals, including leading cross-functional teams to compile review responses.

• Manage interactions with the notified body / MHRA as necessary.

• Keep abreast of the UK and EU IVD regulatory landscape and spearhead the implementation of changes to regulations, standards, and guidelines.

• Represent the organization in UK and EU associations, gathering regulatory intelligence and advocating to shape regulatory policy.

• Work in collaboration with cross-functional teams.

• Provide mentorship and coaching to other associates and cross-functional teams as required.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field with 8 years of experience in the IVD or Medical Device industry, or a Master’s degree in Life Sciences or a related field with 6 years of experience in the IVD or Medical Device industry.

• Over 4 years of experience in Regulatory Affairs related to in vitro diagnostics and/or medical devices, including practical experience with EU IVDR/MDR, UKCA requirements, and management of technical documentation.

• Extensive knowledge of global regulatory requirements and a proven ability to interpret regulations, evaluate compliance impacts, and support regulatory strategies throughout the product lifecycle.

• Strong grasp of Quality Management Systems (QMS), including the application of quality principles, risk management, change control, and post-market activities in a regulated setting.

• Demonstrated ability to effectively collaborate within cross-functional teams and communicate regulatory requirements to both technical and non-technical stakeholders.

• Experience in interacting with notified bodies and regulatory authorities, assisting with submissions, audits, technical reviews, and compliance activities.

• Practical experience with MHRA CTDA regulations and submissions is advantageous.

🏝️ Benefits

• Comprehensive, competitive benefit programs

• Health care program

• Paid time off