Director Regulatory Affairs

An international biotechnology company is recruiting a Director of Regulatory Affairs to join their team based in Cambridge. Proclinical is pleased to announce this exciting opportunity to work with a innovative and revolution organisation whose work in genetic variation and function has allowed for dynamic studies that were previous not even imaginable. The Director of Regulatory affairs will streamline the registration and approval of IVD Medical Devices and platform technologies, whilst leading the RA function in EMEA and providing a strong knowledge of IVD/Med Device registration in EMEA.

Job Responsibilities:

• Lead and manage a compliant European Authorised Representative in an Illumina European legal entity for Illumina Inc. as a legal manufacturer of IVD medical devices placed on the market in Europe.
• Lead and manage EMEA Regulatory Affairs Team.
• Collaborate with Corporate Regulatory Affairs and other related functions to develop product regulatory compliance strategies that meet the requirements of EMEA markets.
• Provide regulatory advice and guidance to EMEA business leadership and support functions to ensure products and services meet regulatory requirements.
• Represent Illumina in relevant regulatory and policy making stakeholder groups and organizations.
• Participate on product development core teams as regulatory representative.
• Interpret and apply regulations by creating regulatory strategies for EMEA markets.
• Write and/or edit submission documents using regulatory templates or create new templates.
• Participate in Material Review Board and complaint/recall meetings.
• Prepare internal procedures for continuous process improvement.
• Mentor junior members of the department.
• Provide regulatory guidance and/or training to external departments and marketing partners.
• Assist in hosting inspections and audits, as needed.
• Assist in conducting internal/external audits, as needed.

Skills and Requirements:

• Requires Bachelor's degree or equivalent, may require an advanced degree, in related field.
• 10+ years related experience or MS degree or equivalent and 6 years related experience or PhD and 4 years related experience.
• Proven experience of interacting with regulatory agencies dealing with matters of compliance with ISO, US FDA, EU and other regulations and standards.
• Broad knowledge of all areas within particular Corporate sub-functions or a function within an operation.
• Requires high level understanding of markets and sales opportunities for the company's products.
• Applicable management experience as assessed by company Executive Staff.
• Demonstrated project management skills.
• 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 Roberto Esposito at +44 203 761 5702 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.

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