Head of Regulatory Affairs

GXpeople are currently supporting manufacturer and supplier of Medical Devices in their search for a Head of Regulatory Affairs. Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. They are transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), so this is a key moment in the company’s history from a Regulatory Affairs perspective. You will be responsible for: Regulatory Affairs activities across all sites. Accountable for ensuring, compliance to the appropriate regulatory standards (ISO13485, Medical directive 93/42/EEC, cGMP and associated standards) with the support of relevant teams. Specific Roles and Responsibilities: Responsible for all matters related to Regulatory Affairs and associated personnel to ensure that the business operates to ISO13485, ISO11135 under the MDD 93/42/EEC including an understanding of the process of moving from the MDD to the MDR (Article 120). Keeps up to date with the regulatory requirements and international standards (ISO 13485,11135 ect). Responsible for maintaining appropriate licenses so that operations can continue across all sites, upholding compliance. Ensures technical documentation including Medical Device files, and EU Declaration of Conformity are correct and kept up to date. Ensures Post market surveillance obligations are complied Responsible for the reporting obligations of Vigilance and Implementing Acts Provide relevant training to staff to increase regulatory awareness. Working with department managers to ensure that the QMSis kept updated Represent the objectives of Regulatory Affairs Department on behalf of the company. Act as department lead and contact for auditors from Regulatory bodies and ensuring that any issues are addressed by the operations team to agreed timeframes. Contributes towards Continuous Improvement initiatives using appropriate tools and principles, e.g. 5 Whys/8D To promote the use of CI tools and principles within the area. To help develop site employees in the CI concepts and progress improvements. Compile technical files and design dossiers, review and assess technical documentation and determine compliance with the MDD / MDR Review and approve product labelling. Approve and oversee product IFUs and other required product labelling in line with relevant EU & international requirements (MDR). Support “virtual manufacturer” suppliers and liaise with EU Competent Authorities and Government Bodies as necessary. Undertakes other administrative tasks to support CE marking and regional registrations. Oversees all registration processes (FDA, SFDA, NBs, Cert bodies, MHRA ect.) Oversee and deliver audits from Notified bodies Responsible for the output of the Laboratories – facilitate, oversee, the day to day running, ensuring all checks, samples, are completed, monitored and results are recorded. Review, update and generate Laboratory validation protocols and Laboratory standards and operating procedures, ensuring compliance. Key knowledge and skills: A broad in-depth knowledge of Regulatory Affairs and CE certification including UKCA. In depth understanding of ISO 13485 requirements and EU MDD & MDR. Ability to read and understand technical material. Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Microsoft Dynamics/Navision. Experienced at reviewing and approving product labelling. Flexible and able to self-manage multiple priorities. Flexibility to work across the UK sites. Education and Experience: Essential: Minimum of 4 years’ experience in Regulatory Affairs or in Quality Management Systems relating to Medical Devices. ISO13485 Internal Auditor experience Extremely strong leadership with a quality compliance background. Must have experience of operating within ISO13485 and the medical device directive (93/42/EEC) or Medical Device Regulatory. Proven experience of effectively leading a team. Relevant regulatory experience which ideally includes the compilation of technical files and design dossiers. Ability to review and assess technical documentation and determine compliance within the Medical Devices Directive Experience / Knowledge of the MDR and can assume the role of “Person Responsible for Regulatory Compliance” (PRRC) as per Article 15 of the MDR. Understands the principles of Sterilisation and is familiar with ISO 11135 If you feel like this could be a good fit for your please apply to this advert or get in touch with me.