Engineer the Quantum RevolutionYour expertise can help us shape the future of quantum computing at Oxford Ionics.

View Open Roles

Regulatory Affairs Department Leader

Edinburgh
3 months ago
Applications closed

Related Jobs

View all jobs

Regulatory Affairs Officer

Quality and Regulatory Manager

Quality Engineer

Regulatory Affairs Specialist

Regulatory Affairs Assistant

Regulatory Affairs Officer

SRG are working with an exciting biotechnology organisation with a global presence to help them find a Department Lead within Regulatory Affairs (RA).

This is a great opportunity for someone with a wealth of experience in the field of Regulatory Affairs within IVD/IVDRs.

The company offer an excellent benefits package and a chance to lead an experienced team.

The role:

Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organisation on RA and Quality strategy and activities
Manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure regulatory compliance with the 98/79/EC IVD Directive (IVDD), Regulation (EU) 2017/746 (IVDR), FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1 as well as regulations required for rest of world submissions.
Interpret complex legislation and provide expert advice on all aspects of US FDA, European and worldwide Regulatory Legislation and collaborative undertakings with external organisations.
Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standard, the 98/79/EC IVD Directive, Regulation (EU) 2017/746 (IVDR), FDA Regulations, Health Canada Medical Device Regulation, Part 1 (SOR/98-282)
Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure the concept of continuous quality improvement is realised.
Lead in the management, planning, co­ordination, preparation and interpretation of relevant information necessary for product licence applications to ensure successful granting, maintenance and development of such licenses by the FDA.
Compile and submit initial registration/approval submissions in international markets post initial submission in EU, USA and other large territories.
Compile product information for the preparation of technical files and regulatory dossiers to support product license applications and product licence maintenance for worldwide Regulatory Authorities.
Review analytical data from laboratory processes, clinical field trials and product evaluation data to support product registration and licence applications.
Advise on data and information required for successful licence applications and registrations and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
Lead RA team in the assessments of product changes for impact to existing registration/approvals.
Compile and submit product change notifications to regulatory agencies as required
Support and guide team members in the preparation of technical files and regulatory dossiers to support product licence applications and product licence maintenance for the worldwide regulatory authorities.
Serve as Company contact for regulatory/registration activities with third party business partners.

Requirements:

A relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applications.
Extensive post-market experience ensuring ongoing regulatory compliance
Significant specialist knowledge of regulatory affairs as applied to in vitro diagnostic medical devices and an understanding of the operation of a medical device manufacturing establishment.
Understanding of budgetary process and requirements for managing a department.
Previous department management experience with strong leadership skills to manage a team. High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same.
Effective relationship building, negotiation and influencing skills both internally with other functional teams and externally with regulatory bodies, customers and distributors.
Strong time management and prioritisation skills, able to work in a fast-paced work environment and respond flexibly to meet changing deadlines and priorities.
Continued interest in updating own knowledge and skills and transferring knowledge to others.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Pre-Employment Checks for Medical Technology Jobs: DBS, References & Right-to-Work and more Explained

Pre-employment screening in medical technology reflects the discipline's unique position at the intersection of healthcare innovation, regulatory compliance, and patient safety management. Medical technology professionals often have privileged access to sensitive patient data, proprietary medical devices, and clinical systems that form the foundation of healthcare delivery and patient care outcomes across the NHS and private healthcare sectors. The medical technology industry operates within stringent regulatory frameworks spanning MHRA device regulations, GDPR healthcare provisions, and emerging digital health governance requirements. Medical technology specialists must demonstrate not only technical competence in healthcare systems and medical device development but also deep understanding of clinical safety protocols, patient data protection, and the ethical implications of healthcare technology deployment at scale. Modern medical technology roles frequently involve developing diagnostic systems, patient monitoring devices, healthcare AI applications, and clinical information systems across multiple regulatory jurisdictions and clinical safety frameworks simultaneously. The combination of technical expertise, patient safety responsibility, and regulatory compliance requirements makes thorough candidate verification essential for maintaining clinical governance, patient safety, and public trust in healthcare technology systems.

Why Now Is the Perfect Time to Launch Your Career in Medical Technology: The UK's Healthcare Innovation Revolution

The United Kingdom stands at the epicentre of a medical technology revolution that's fundamentally transforming how we diagnose disease, deliver treatment, and improve patient outcomes across the entire healthcare spectrum. From the AI-powered diagnostic systems revolutionising radiology departments in London to the robotic surgery platforms advancing precision medicine in Edinburgh, Britain's leadership in healthcare innovation has created an unprecedented demand for skilled medical technology professionals that dramatically exceeds the current talent supply. If you've been seeking a career that combines cutting-edge technology with meaningful human impact or looking to position yourself in one of the most essential and resilient sectors of the modern economy, medical technology represents an extraordinary opportunity. The convergence of digital health transformation, ageing population demographics, precision medicine advancement, and healthcare system modernisation has created perfect conditions for medical technology career success.

Automate Your Medical Technology Jobs Search: Using ChatGPT, RSS & Alerts to Save Hours Each Week

Medtech roles drop across device makers, diagnostics, digital health/SaMD, imaging, robotics, NHS suppliers, pharma/biotech platforms & notified bodies—often buried in ATS portals or duplicated across boards. The fastest way to stay on top of them isn’t more scrolling; it’s automation. With keyword-rich alerts, RSS feeds and a reusable ChatGPT workflow, you’ll bring relevant roles to you, triage them in minutes and tailor strong applications without burning your evenings. This copy-paste playbook is for www.medicaltechnologyjobs.co.uk readers. It’s UK-centric, practical and designed to save you hours each week. What You’ll Have Working In 30 Minutes A role & keyword map spanning Regulatory, Quality, Design & Development (HW/SW/Systems), Clinical/Usability, Manufacturing/Operations, Field Service, and Commercial-adjacent. Shareable Boolean searches you can paste into Google & job boards to slice through noise. Always-on alerts & RSS feeds delivering fresh UK roles to your inbox/reader. A ChatGPT “MedTech Job Scout” prompt that deduplicates, scores fit and outputs tailored actions. A lightweight pipeline tracker so deadlines and follow-ups never slip.