Regulatory Affairs Manager

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 Manager. 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 requires the post-holder to take operational responsibility for the creation and implementation of OGT regulatory strategies, and accountability for the delivery of regulatory tasks by members of their team. The role has many facets, from pre-market to post-market, and includes oversight of vigilance and product recall activities, as well as driving the regulatory strategy for new/updated product development.

What you’ll be doing for us

• Maintain knowledge of the Company’s portfolio with respect to the technical and scientific environment, clinical purpose, and regulatory framework.
• Proactively plan, manage and drive the regulatory strategy, submission and approval requirements for new product developments and product/manufacturing changes, leading developmental teams on regulatory requirements.
• Liaise effectively with product managers, product development team managers, operations managers, and other stakeholders to ensure timely completion of tasks in support of regulatory submissions.
• Act as Subject Matter Expert (SME) and Regulatory Affairs (RA) lead for the product development projects, providing "solution-based" advice to development teams.
• Update on the progress of registration processes and other RA group activities to line management or project teams when requested.
• To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
• Accountable to the EVP for upkeep of submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
• Work with internal and external stakeholders to review and approve labelling, advertising, and promotional items to ensure regulatory compliance.
• Manage interactions with authorised representatives, distributors, 3 rd 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 (QMS).
• Accountable for the delivery of risk management processes; ensure risk management files are developed, followed, and implemented.
• Accountable for the delivery of post market surveillance activities.
• Accountable for the delivery of procedures for dealing with products that require corrective action and reporting (vigilance), ensuring the appropriate activities are completed within required timelines.
• Manage and develop 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, approve the regulatory impact of product changes.
• Develop regulatory submission strategies to facilitate the timely commercialisation of new or modified products in global markets.
• Where appropriate, review and approve technical documentation, risk analysis, performance evaluation studies, and other documentation for submission filing. Accountable for ensuring correct documentation is generated to appropriate standards.
• Review and approve risk management documentation.
• Manage, and report where required, 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 EVP.
• Review the impact of changes to standards and legislation and help manage any required conformance and change activities. Report any impacts to EVP.
• Monitor pending regulatory submissions, registration process or other RA group activities to ensure timely delivery. Communicate to management any identified delays that may impact business expectations.
• To interact with regulatory consultants, regulatory and trade associations and other third-party service providers to ensure their provision of any requested activities to agreed timescales.
• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices
• Supply reports, reviews, or summaries of KPIs to the OGT Executive team as required.
• Subject to possession of the required qualifications, and if so designated in the Company’s Strategy for Regulatory Compliance and/or Organisation Chart, to act as the/a Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the European IVD Regulation (EU) 2017/746.
• Play an active role in engagement/leadership/people management activities within the RA department.
• Advising on and reviewing company structure to ensure efficiencies, working to a budget.
• Manage and implement training programmes for junior employees.

What we are looking for in you

• Degree level education or equivalent, in life sciences
• >5 years of previous experience in IVD and/or medical device regulation (preferably EU-related)
• Holds a recognised qualification in Regulatory Affairs
• Evidence of CPD
• Experience of working to ISO 13485
• Ability to independently-manage multiple projects, department initiatives, and day-to-day tasks.
• 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:

• Private Health Insurance
• Group Income Protection
• Group Life Assurance
• High Street Discount Scheme.

Application is via CV and 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.

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