Head of Regulatory Affairs - Medical Devices

A global health tech company is advertising a vacancy for a Head of Regulatory Affairs - Medical Devices, based in the company's office in London. The organisation works with world-leading healthcare providers, pharmaceutical, insurance, and technology companies to build a connected digital health ecosystem. This is an exciting opportunity to work with a company that has partnered with internationally renowned organisations and that has offices around the globe.

Job Responsibilities:

• Create and maintain regulatory documentation, preparing regulatory submissions (such as technical files), and managing the regulatory submission process for global submissions (including CE marking, FDA, China, ROW).
• Develop strategies and submissions for complex products to gain approvals for commercial distribution and clinical research in various geographies.
• Defining requirements and the processes for preparing technical and regulatory documentation and submissions.
• Ensuring our processes are compliant with relevant industry standards and medical devices requirements (such as ISO 13485, FDA CFR Title 21 Part 820, EU Medical Device Directive/ Regulation (MDD/MDR), EN/IEC 62304, ISO 14971, etc.).
• Work with the company team to develop world-class approaches to clinical trials and evaluation, providing guidance and support including design verification, pre-clinical, and clinical studies.
• Ensuring related training is provided where needed to comply with relevant industry standards, medical devices requirements, and internal policies and procedures.
• Supporting the development of quality products to help achieve company goals and ensure all lessons learned and appropriate changes are implemented (e.g. processes that support the lifecycle of medical devices such as design control, design change, design verification & validation, integration and deployment testing, post-market surveillance, and handling customer complaints).
• Core quality assurance and compliance activities such as conducting internal audits, preparing management reviews, CAPA management etc., as well as strict and consistent risk management activities.
• Managing notified body audits or any competent authority or regulatory body inspections Leading on the development of our QMS for a scaling team and for new territories as the company grows, including becoming MDSAP compliant and certified.
• Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, development, manufacturing, and labelling.
• Ensure that post-market surveillance obligations are met, and that requirements for submission of vigilance reports are complied with.
• Act as liaison between Clinical, Regulatory, Research, Partner, Trial Unit, Engineering, Product, Design and Legal Teams.
• Lead proactive and continuous improvements for Regulatory Affairs and in support of the quality system.

• Maintain knowledge on changing worldwide regulations and standards that are relevant to company.

Skills and Requirements:

• Experience working in healthcare and/or with software medical devices.
• Understanding and experience with MDSAP and ISO 13485, FDA QSR 21 CFR 820, MDD/ MDR, EN/IEC 62304, ISO 14971, and similar standards and regulations.
• Awareness of changing worldwide regulations and standards that are relevant to medical devices such as the MDR.
• Experience writing and preparing submissions globally including CE marking and FDA.
• Providing advice to teams conducting clinical evaluations and clinical investigations in accordance with the MDD, MEDDEV and ISO 14155:2011.
• The CE marking process including implementation of an ISO certified Quality Management System and interactions with Notified Bodies and the MHRA.
• Device vigilance including the reporting requirements to the MHRA and ongoing PMS.
• Supporting product development teams in collating and keeping up to date product technical documentation, regulatory documentation, and declarations of conformity.
• Excel in writing easy-to-follow policies and procedures.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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