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 our client meets 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.
The ideal candidate:
* 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.
* Regulatory requirements. Detailed working knowledge of regulatory authority expectation regarding submissions and maintenance (e.g. IVDD/IVDR/FDA QSR).
* Able to understand how technical standards are applied to aid the development of IVD and general professional products.
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