TÜV SÜD
Conformity Assessment Procedure Specialist (CAPS) - UKCA & Global Regulatory Affairs Specialist
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About TÜV SÜD Group
At TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.
Role Overview
Responsible for ensuring procedural compliance of TÜV SÜD UKCA conformity assessment activities with applicable UKCA requirements, jurisdictional requirements, expectations and internal quality management system requirements.
Working alongside Global Regulatory colleagues acting as a global regulatory specialist supporting key regulatory determinations, leading on authority led requests and supporting in driving forward CAPA’s.
Responsibilities
- Assure all applicable processes remain compliant with UKCA requirements.
- Maintain overall compliance of the UKCA scheme and associated procedures.
- Review UK Regulations and guidance documents and coordinate implementation activities.
- Conduct gap assessments and monitor closure of identified compliance gaps.
- Identifies regulatory risks and create awareness among relevant managers and process owners
- Review new and revised procedures, guidelines, training materials and QMS documents for UKCA compliance.
- Support Regulatory assessments, resolution of audit findings, appeals and CAPA activities.
- Provide technical and regulatory guidance to stakeholders and support UKCA training activities.
- Attend internal and external UKCA related technical meetings, driving forward key topics, representing TUV SUD’s interests
- Work in close alignment with the relevant colleagues to drive forward strategic and operational issues.
- Work in close alignment with the wider CAPS community to ensure alignment
- Where required, support with the liaison with relevant regulatory authorities
- Act as a conduit and link of information sharing between the UK Approved Body & Global Regulatory Affairs
- Act as a global regulatory specialist supporting in key regulatory determinations
- Support with global authority enquiries of a complex nature ensuring investigation and responsiveness in required timeframe
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Education & Experience
- University degree in science, engineering, medicine, pharmacy or related discipline.
- Minimum 5 years’ medical device regulatory experience with a deep understanding of applying and interpreting the UKMDR & EU MDR/IVDR requirements
- Skilled and comfortable in addressing audiences in the following scenarios: audit, training and external representation activities
- Previous experience in handling of complex regulatory determinations
- Ability to bring practical solutions to complex regulatory scenarios
- Skilled at concise communication
- Ability to effectively work across varied cultures and regions
- Ability to make effective independent judgments and decisions consistent with TÜV SÜD’s policies – i.e. “think on your feet”
- Demonstrates critical analytical skills and attention to detail
- Excellent English written and verbal skills, as demonstrated by ability to write standards and regulatory guidance
- Previous auditor experience is desirable but not essential
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Diversity & Inclusion
At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.
We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values.
We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group.
Job Details
- Work Area: Medical Devices & Healthcare
- Country/Region: United Kingdom
- Job Location: Fareham
- Working Model: Home-Office
- Employment Type: Full time / regular
- Company: TUV SUD Ltd.
- Org Unit Code
- Requisition ID: 6647
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