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Senior Director Regulatory Affairs

2 months ago

Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

About Us
Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths.
Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer real-time nanopore-based DNA/RNA sequencing technology: accessible, easy to use and fully scalable for any requirement.
Summary
Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT's unique and market leading nanopore-based next generation gene-sequencing (NGS) technology. In addition to selling its technologies and products into research use only applications, the firm also markets IVD instruments (using the same highly complex, unique NGS technology). ONT also develops its own assays and directly collaborates with a wide range of third parties to support the development of assays by those parties. Design and manufacturing are based in Oxford but ONT products are marketed globally (into both RUO and IVD markets). Consequently, the firm's IVD instruments and assays are subject to regulations in the territories in which they are sold and regulatory filings must be made to the relevant health care authorities. To ensure that products conform with relevant regulations in territories in which they are sold OND, and ONT, operates two Quality Management Systems (ISO 13485-OND & ISO9001-ONT). The role of the Senior Director Regulatory Affairs is responsible for ensuring the firm fully complies with its regulatory obligations, to oversee the operation and functions of the Regulatory Affairs team and to ensure compliance with its QMS (by working with the Head of Quality Assurance).
Key Responsibilities:
The postholder is responsible for the overall management of the Regulatory, Risk Management (product, software, process etc.), PMS and Clinical Affairs functions and for conducting a wide range of duties to ensure that both OND and ONT meet their regulatory obligations with regards to product development, manufacture and distribution. Where appropriate some duties may be delegated to suitably experienced/qualified staff.
The post holder shall have the authority to review and approve product regulatory processes, documents and records.
Duties include, but are not limited to:

  • As detailed in the firm's QMS and SOPs to fulfilling part or all the function of "Person with Regulatory Responsibility" as per the EU IVDR.
  • Manage the Regulatory, Risk Management, PMS and Clinical Affairs functions.
  • Establish strong working relationships across the business to facilitate best practices in the risk management, product development, testing, manufacture and post market surveillance of products.
  • To lead all Health Authority interactions and communications (pre-submissions, submissions, recalls etc.).
  • To regularly monitor data outputs from functions which have regulatory relevance e.g. complaints and customer feedback.
  • Provide regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements.
  • Ensure the business is updated with regulatory expectations and intelligence.
  • Ensure training on regulatory processes is developed and maintained and assigned appropriately.
  • Establish and maintain an effective Post Market Surveillance system to meet regulatory requirements.
  • Provide regulatory support to internal and external audits and inspections.
  • Support and progress the compilation of regulatory submissions.
  • Provide regulatory support in the correct application of technical standards to meet regulatory requirements and industry best practices. To cooperate with the Head of QA in the strategy and development of the QMS.:
  • As detailed in the firm's QMS and SOPs to fulfilling part or all the function of "Person with Regulatory Responsibility" as per the EU IVDR.
  • Manage the Regulatory, Risk Management, PMS and Clinical Affairs functions.
  • Establish strong working relationships across the business to facilitate best practices in the risk management, product development, testing, manufacture and post market surveillance of products.
  • To lead all Health Authority interactions and communications (pre-submissions, submissions, recalls etc.).
  • To regularly monitor data outputs from functions which have regulatory relevance e.g. complaints and customer feedback.
  • Provide regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements.
  • Ensure the business is updated with regulatory expectations and intelligence.
  • Ensure training on regulatory processes is developed and maintained and assigned appropriately.
  • Establish and maintain an effective Post Market Surveillance system to meet regulatory requirements.
  • Provide regulatory support to internal and external audits and inspections.
  • Support and progress the compilation of regulatory submissions.
  • Provide regulatory support in the correct application of technical standards to meet regulatory requirements and industry best practices. To cooperate with the Head of QA in the strategy and development of the QMS.

Qualifications/Experience:

  • Qualification to BSc level or higher in relevant scientific subject area or proven experience in working in a relevant regulatory role.
  • A minimum of 5 years' experience in a senior regulatory management role (with significant quality contribution/responsibility) in the IVD industry, with management responsibility for a team of >5. Specifically this experience should include in-depth work with both complex instrumentation and IVD assays.
  • Direct experience of assembling and submitting FDA 510k and CE Tech File (to IVDR) reviews
  • Detailed understanding of risk management, process validation, clinical validation, electrotechnical instrumentation compliance and IVD V&V standards.
  • Experience of working in an IVD environment along with practical experience in working to applicable standards (e.g. ISO 13485, ISO 14971, ISO 9001).
  • Strong working knowledge of regulatory requirements applicable to IVD devices.
  • Hands-on experience with leading teams to achieving compliance to at least two of the following: IEC 62304, IEC 62366, GLP, EMC

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.