Regulatory Affairs Manager

TOGL(Holdings)Limited is a diagnostics company focused on diseases of the gastrointestinal tract. Our current research and validation programme targets accurate and efficient triage of patients with symptoms of colorectal cancer (CRC). We are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company. As we progress towards commercialising a test for CRC, we are looking for a Regulatory Manager to lead the development process through relevant regulatory pathways.

Responsibilities:

• Lead Regulatory Affairs activities for medical devices, in vitro diagnostic medical devices (IVDs), including software as an IVD (SaMD) and genomic diagnostic technologies.
• Develop, maintain and update Technical Documentation in accordance with EU MDR, IVDR and other applicable regulatory requirements.
• Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management.
• Prepare and maintain regulatory documentation including Technical Files, Risk Management Files, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and associated technical documentation.
• Provide regulatory input throughout the product development lifecycle, ensuring compliance with design control, verification, validation and change management processes.
• Lead regulatory activities relating to analytical performance, clinical performance, scientific validity and software validation.
• Support Post-Market Surveillance (PMS), vigilance, trend reporting and regulatory compliance activities.
• Conduct regulatory impact assessments and provide guidance on product, manufacturing and quality system changes.
• Work collaboratively with R&D, Software, Bioinformatics, Clinical and Quality teams to ensure regulatory requirements are integrated into product development.
• Support regulatory submissions, Notified Body interactions and market access activities within the EU, UK and other international markets.
• Provide regulatory training and technical guidance to internal teams and support the Person Responsible for Regulatory Compliance (PRRC) where required.
• Monitor changes to relevant regulations, standards and guidance, assessing their impact on the business and products.

Requirements

• Degree in Biomedical Science, Molecular Biology, Genetics, Life Sciences or a related scientific discipline.
• Significant Regulatory Affairs experience within the medical device and/or in vitro diagnostic (IVD) industry.
• Strong working knowledge of the EU In Vitro Diagnostic Regulation (IVDR (EU) 2017/746) and Medical Device Regulation (EU MDR 2017/745).
• Demonstrable experience developing and maintaining Technical Documentation for medical devices and/or IVDs.
• Experience supporting the regulatory development of novel IVD technologies, including genomic, molecular and software-based diagnostics.
• Experience with Software as an IVD (SaMD) and an understanding of software lifecycle and validation requirements (e.g. IEC 62304).
• Strong understanding of design control, product lifecycle management and regulatory change management.
• Hands-on experience with Risk Management in accordance with ISO 14971.
• Experience preparing or contributing to Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and Post-Market Surveillance (PMS) documentation.
• Experience supporting regulatory submissions and interactions with Notified Bodies and Competent Authorities.
• Working knowledge of ISO 13485 and associated regulatory standards.
• Excellent written and verbal communication skills, with the ability to communicate effectively across multidisciplinary teams.
• Highly organised, pragmatic and able to manage multiple regulatory projects within a fast-paced development environment.
• Excellent written and verbal communication skills in English. 

Desirable

• Experience with Class C IVDs under IVDR.
• Experience supporting AI-enabled or bioinformatics-driven diagnostic technologies.
• Experience with analytical performance, clinical performance and scientific validity studies.
• Experience with UKCA, FDA or other international regulatory frameworks.
• Previous experience acting as, or supporting, the Person Responsible for Regulatory Compliance (PRRC).

Benefits

• 25 days annual leave (plus bank holidays).
• Pension contribution.
• Competitive Salary.
• Employee wellbeing initiatives.