GXpeople are currently supporting a manufacturer and supplier of Medical Devices in their search for a Head of Regulatory Affairs.
They are transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), making this a key moment in the company's history from a Regulatory Affairs perspective.
You will be responsible for:
Regulatory Affairs activities across all sites, ensuring compliance with 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 understanding the process of moving from the MDD to the MDR (Article 120). Keep up to date with regulatory requirements and international standards. Maintain appropriate licenses to ensure operations can continue across all sites, upholding compliance. Ensure technical documentation, including Medical Device files and EU Declaration of Conformity, is correct and kept up to date. Ensure compliance with post-market surveillance obligations. Report on vigilance and implementing acts obligations. Provide relevant training to staff to increase regulatory awareness. Work with department managers to ensure that the QMS is kept updated. Represent the objectives of the Regulatory Affairs Department on behalf of the company. Act as department lead and contact for auditors from regulatory bodies, ensuring that any issues are addressed by the operations team to agreed timeframes. Contribute to Continuous Improvement initiatives using appropriate tools and principles, e.g., 5 Whys/8D, and promote the use of CI tools and principles within the area. Compile technical files and design dossiers, review and assess technical documentation, and determine compliance with the MDD/MDR. Review and approve product labeling, including overseeing product IFUs and other required product labeling in line with relevant EU & international requirements (MDR). Support “virtual manufacturer” suppliers and liaise with EU Competent Authorities and Government Bodies as necessary. Undertake other administrative tasks to support CE marking and regional registrations, overseeing all registration processes (FDA, SFDA, NBs, Cert bodies, MHRA, etc.). Oversee and deliver audits from Notified Bodies. Responsible for the output of the Laboratories, facilitating and overseeing day-to-day operations, ensuring all checks and samples are completed and 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 labeling. Flexible and able to self-manage multiple priorities. Flexibility to work across the UK sites.
Education and Experience: 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. Proven experience of effectively leading a team. Relevant regulatory experience, ideally including 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 ability to assume the role of “Person Responsible for Regulatory Compliance” (PRRC) as per Article 15 of the MDR. Understanding of the principles of Sterilisation and familiarity with ISO 11135.
If you feel like this could be a good fit for you, please apply to this advert or get in touch with me. #J-18808-Ljbffr
They are transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), making this a key moment in the company's history from a Regulatory Affairs perspective.
You will be responsible for:
Regulatory Affairs activities across all sites, ensuring compliance with 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 understanding the process of moving from the MDD to the MDR (Article 120). Keep up to date with regulatory requirements and international standards. Maintain appropriate licenses to ensure operations can continue across all sites, upholding compliance. Ensure technical documentation, including Medical Device files and EU Declaration of Conformity, is correct and kept up to date. Ensure compliance with post-market surveillance obligations. Report on vigilance and implementing acts obligations. Provide relevant training to staff to increase regulatory awareness. Work with department managers to ensure that the QMS is kept updated. Represent the objectives of the Regulatory Affairs Department on behalf of the company. Act as department lead and contact for auditors from regulatory bodies, ensuring that any issues are addressed by the operations team to agreed timeframes. Contribute to Continuous Improvement initiatives using appropriate tools and principles, e.g., 5 Whys/8D, and promote the use of CI tools and principles within the area. Compile technical files and design dossiers, review and assess technical documentation, and determine compliance with the MDD/MDR. Review and approve product labeling, including overseeing product IFUs and other required product labeling in line with relevant EU & international requirements (MDR). Support “virtual manufacturer” suppliers and liaise with EU Competent Authorities and Government Bodies as necessary. Undertake other administrative tasks to support CE marking and regional registrations, overseeing all registration processes (FDA, SFDA, NBs, Cert bodies, MHRA, etc.). Oversee and deliver audits from Notified Bodies. Responsible for the output of the Laboratories, facilitating and overseeing day-to-day operations, ensuring all checks and samples are completed and 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 labeling. Flexible and able to self-manage multiple priorities. Flexibility to work across the UK sites.
Education and Experience: 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. Proven experience of effectively leading a team. Relevant regulatory experience, ideally including 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 ability to assume the role of “Person Responsible for Regulatory Compliance” (PRRC) as per Article 15 of the MDR. Understanding of the principles of Sterilisation and familiarity with ISO 11135.
If you feel like this could be a good fit for you, please apply to this advert or get in touch with me. #J-18808-Ljbffr
