Regulatory & Risk Manager

Regulatory & Risk Manager

We are acting on behalf of a very successful and highly innovative medical devices manufacturer in the Birmingham area. This company has created waves on a global scale with their innovation and due to steady growth and success, they now have several positions on offer within their technical team.

The role:

Due to significant growth, our client now has the requirement to bring in someone to take control of the regulatory and risk management function of this role. The primary function will therefore be to develop a regulatory strategy to support all target markets and to ensure regulatory compliance as required.

To that extent, you will be responsible for:

• Providing sufficient depth of evidence to demonstrate regulatory compliance;
• Driving the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in the UK, US, Europe and other markets as required;
• Delivering PMS requires, vigilance reports and clinical evaluation reports in line with relevant plans;
• Defining regulatory pathways for entry into global markets and supporting other members of the company in their understanding of these pathways;
• Providing evidence on possible approaches to de-risking and accelerating project completion;
• Giving advice on approaches taken by other companies for comparable products in satisfying regulatory requirements;
• Providing risk assurance support into the design and development process; to assure risk consideration and acceptability as ALAP throughout the product development life cycle;
• Line managerial responsibility to the RA team and ensuring that there is a common agreement on strategy, priorities and deadlines and maintaining strong understanding of delivery against plans and targets;

The candidate:

The ideal candidate will:

• Possess experience of working with PEMS (programmable electrical medical systems) or equivalent high-integrity, software-intensive systems ie complex devices requiring multidisciplinary development effort (mechanical engineering, software electronics, system integration, pneumatics, fluid mechanics etc);
• Have experience of working with risk management, regulatory requirement, document management systems, issue management systems;
• Be trained in the application of ISO 14971;
• Work with external bodies;
• Have excellent team management and communication skills;
• Possess exceptional internal and external senior stakeholder engagement skills and ability;
• Have an eye for detail and possess technical knowledge of product base and application.

Essential skills and experience:

• Experience as a regulatory manager with line managerial responsibility/management experience;
• 510k and FDA submission experience;
• Strong understanding of regulatory standards and their implementation in a Medical Device framework ie Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11.

This company is headed in a very exciting direction and this could be a seriously career-making role for the right individual. For a confidential chat, please contact Mohsin Patel.

Salary: GBP60,000 - GBP70,000 + bonus + share options + benefits

Location: Birmingham, Midlands