Regulatory Affairs – Medical Devices (Remote)

Salary: £66,000 – £78,000 per year

Do you want to join a team where you are supported and enabled to develop a career that enhances your life and the life of others?
If you do, we want to hear from you as we have an exciting Consultant- Medical Devices Regulatory Affairs role within our growing Regulatory team.
Broughton is a global scientific consultancy-based Contract Research Organisation (CRO) with in-house laboratory testing capabilities, rapidly developing its position as a full-service solutions provider to the life sciences sector.
The Regulatory Affairs team is a group of experienced subject matter consultants that offer regulatory expertise across the full product life-cycle, i.e. regulatory strategy/pathways, dossier compilation/submission and post-submission maintenance
The role of the Consultant- Medical Device Regulatory Affairs is to lead the organisations activities in medical device development, registration and maintenance, on a global basis. The role holder is expected to demonstrate proven experience and leadership in medical device approval.
Main Purpose of Job
• Provide expert advice to internal and external stakeholders to support the design, development, and successful approval of medical device(s)
• Develop and manage appropriate technical device files on behalf of clients
• Design and place appropriate work packages (studies, process, files etc) to meet applicable regulatory guidance i.e. EU MDR/MDD, FDA
• Act as point of contact and interface with notified (Authorised) bodies
• Lead and/or author high-quality regulatory documents for global submissions supporting medical devices
• Interpretate regulatory legislation/guidelines and ensure compliance across the development and registration lifecycle
• With the Head of Regulatory Affairs and SMEs develop agreed regulatory strategies and pathways for clients
• Participate in regulatory due diligence and gap assessments on behalf of clients
• Maintain an up-to-date knowledge of global regulations
• Provide guidance, training and mentorship to junior colleagues
• Develop and refine the regulatory function within the organisation
Key Person Specifications
Pharmacy, biology, chemistry or engineering science degree; higher degree in one of these fields is preferred
Extensive experience (7 years+) in a medical device regulatory affairs role including product development
Thorough knowledge and understanding of medical device development and registration i.e. EU MDD, UK MDD, FDA, ISO
Knowledge of key regulatory pathways for pharmaceutical products and drug-device combinations would be of benefit
Hands-on experience in the authoring of technical files or DMF
Experienced in liaising with notified (Authorized) bodies and other regulatory agencies
Experience of post-marketing activities would be welcome, as would experience in risk management
Ability to engage across multiple work-streams and liaise with all stakeholders to achieve project deliverables
Excellent communication skills, written and verbal
Ability to help drive and shape the department going forward
4 Key Tasks and Accountabilities
Accountable for the provision of consultancy level advice to internal and external stakeholders in relation to medical device development and approval
Lead and author reports, technical files, assessments, and submissions in relation to medical devices
Provide authoritative regulatory input on global registration strategies and pathways
Design, develop and implement work programmes leading to CE/CA marking of clients’ devices
Strive to identify and subsequently action process and operational improvements with the regulatory function
Assist in the training and mentoring of junior staff
Represent the regulatory function at an appropriate level within the business
Maintain an excellent knowledge of global device regulatory affairs and disseminate how any changes in this environment may impact the business or clients
Be able to work across multiple regulated pathways i.e. TPD, PMTA, Drug-Device Combinations, Medicinal Pharmaceuticals