As part of the certification body (TÜV SÜD BABT), this role will have the key responsibility for the final review and certificate decisions for the UK Approved Body scheme for medical devices.

Main Duties and Responsibilities:

• Handling of final review and certification of conformity assessment processes according to the UKCA scheme for medical devices
• Support the activities required for the application and maintenance of TÜV SÜD BABT designation and accreditation as a UK Approved Body for medical devices under the UKCA Scheme
• Support the UK Approved Body conformity assessment teams to clarify technical questions
• Support the technical handling of appeals from manufacturers
• Support the certification body in the interactions with authorities and accreditors
• Carry out technical evaluations and making the final decision regarding certifications and maintenance of certification
• Where required, deputise for the Head of the Approved Body
• Conduct internal audits within the certification body and its subsidiaries
• Support the technical processing of client vigilance information and incidents
• Support the training and monitoring of technical certifiers
• Support the qualification and authorisation of conformity assessment staff
• Representing the Certification Body in companywide working groups and industry peer groups

Essential Criteria – the successful candidate will have, or be able to demonstrate:

• A degree (or equivalent) in a relevant engineering or natural sciences discipline.
• At least 4 years’ experience in the medical device/IVD industry with specific experience working with IVD medical devices (e.g. in design, manufacture, test, use).
• A good-to-thorough understanding of the EU and / or UK regulatory requirements for IVDs  (EU IVDD/IVDR, UK MDR 2002 Part IV) and experience working in a certification body (e.g. EU Notified Body or Approved Body) performing conformity assessment work as an auditor or product reviewer.
• Knowledge of quality and accreditation standards (e.g. ISO 17065, ISO 17021, ISO 13485, MDSAP)
• Strong understanding of medical device regulations and QMS standards and their interpretation.
• A good team player with a positive “can-do” attitude who actively and positively engages with colleagues with a proactive approach to change and self-development.
• Strong work ethic and social competence as well as client service skills to ensure an effective and responsive interaction with clients (internal and external).
• Ability to maintain composure and work well under pressure in challenging situations and to ensure compliance with regulations and protection of business interests.
• Must have an ability for critical, analytical and pragmatic thinking.
• Must have strong verbal and written communication skills.
• Must be self-motivating, proactive and must be able to adapt in challenging situations.
• Must be willing to undertake travel within the UK and internationally (up to 10% of working time)
• Our core values are “Own it”, “Improve it” & “Make it Positive” – candidates who possess this mind set, and who look to continually strive for improvement, in both their direct and in-direct areas of responsibility are those who excel at TÜV SÜD
• Ability to handle confrontation with appropriate grace, professionalism, and firmness to manage/resolve disputes appropriately.
• Ability to communicate concepts in elegant, concise, eloquent form to management and to cross-functional departments or teams verbally, in writing, and through pictures or diagrams when appropriate.

Additional information

Candidates for this role must be based in, or willing to relocate to, the UK for employment. 

Further Information:

TÜV SÜD in the UK offers a competitive salary and benefits package that includes a minimum of 33 days holiday entitlement (for full-time employees, including public holidays), a contributory Group Personal Pension Plan and a non-contributory Group Life Assurance Scheme. We also offer various Salary Exchange/Sacrifice schemes (buying/selling holiday, cycle to work scheme, pensions), incentive schemes and comprehensive wellbeing support (Employee Assistance Programme, Dental Scheme and Occupational Health services). Dependent on their role, employees may also be eligible for hybrid/permanent home-working, a Company Car/Car Allowance and Private Medical Insurance.