Regulatory Affairs Specialist

OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs Specialist. Our Regulatory and Medical Affairs team is responsible for ensuring that OGT’s products are safe, effective, and fit for purpose, thus allowing them to be available globally and state of the art.

This role plays a pivotal part of the team, enabling the organisation to meet the business and regulatory compliance requirements of the markets in which its products are developed, performance evaluated, clinically validated, manufactured and/or distributed.

What you’ll be doing for us

• Maintain a good knowledge of specific country/regional regulatory frameworks as assigned.
• Maintain knowledge of the Company’s portfolio with respect to the technical and scientific environment, clinical purpose, and regulatory framework.
• Provide input into the regulatory strategy, submission and approval requirements for new product developments and product/manufacturing changes.
• Liaise with key stakeholders to ensure timely completion of tasks in support of regulatory submissions.
• Provide input and technical guidance on regulatory requirements to development teams as required.
• Update on the progress of registration processes and other RA group activities to line management when requested.
• Organise consular and translation services.
• To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
• Maintain all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
• Review labelling, advertising, and promotional items to ensure regulatory compliance.
• Liaise with Authorised Representatives, distributors, 3rd parties and international regulatory agencies and provide supporting documentation, handle queries issues and complaints.
• Liaise with product managers and other key stakeholders to maintain product technical documentation and records supporting the Quality Management System.
• Review and authorise technical documentation, product specifications, risk analysis, performance evaluation studies, clinical literature, and documentation for submission filing. Coordinate with other departments to ensure correct documentation is generated to appropriate standards
• Generate and review risk management documentation; ensure risk management files are developed, followed, and implemented.
• Develop and maintain post market surveillance activities.
• Maintain and execute procedures for dealing with products that require corrective action and reporting (vigilance), ensuring that activities are completed within required timelines.
  
• Carry out periodical reviews of worldwide regulatory framework for existing and new markets, liaise with key stakeholders to maintain QMS processes and submission of documentation for the continuing compliance of the Company’s portfolio.
  
• In conjunction with appropriate stake holders, review the regulatory impact of product changes.
  
• Develop regulatory submission strategies to facilitate the timely commercialisation of new or modified products in global markets.
  
• Carry out safety officer responsibilities including the use of Trackwise.
  
• To complete any other tasks as commensurate with the level and nature of the post as delegated by the RA Manager.
  

What we are looking for in you

Essential

• Degree level education or equivalent, in life sciences
  
• >3 years of previous experience in IVD and/or medical device regulation (preferably EU-related)
  
• Holds a recognised qualification in Regulatory Affairs.
  

Desirable

• IVD expertise (preferably EU-related)
  
• Experience of working to ISO 13485 as well as 21 CFR Part 820
  
• Experience in post market surveillance activities, vigilance and recall activities
  
• Experience of dealing with Competent Authorities, global regulators and notified bodies.
  

In return you will receive:

• Competitive salary
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• Private Dental Insurance
• Group Income Protection
• Group Life Assurance
• 25 days holiday plus UK bank holidays
• High Street Discount Scheme.

Application is via CV & a one-page covering letter outlining your suitability for the role, salary expectations and notice period

Please note that we will need to establish your right to work during the recruitment process.