Medical Device Audit Lead
4 weeks ago
Medical Device Audit Lead
As a Medical Device Audit Lead at TÜV SÜD, you will be responsible for performing medical device audits in accordance with applicable regulations and standards. Your duties will include auditing clients per Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g. ISO 13485, ISO 14971). You will also perform related tasks such as scheduling, planning, reviewing corrective actions, and preparing reports and audit documentation for submission to the certification committee of the Notified Body.
Key Responsibilities:
- Auditing: Perform regulatory audits of clients per Medical Device Regulations (IVDR, MDR); Medical Device Single Audit Program (MDSAP); international quality system standards (e.g. ISO 13485, ISO 14971); and internal Notified Body and TÜV SÜD America criteria.
- File Reviews: Perform evaluations of regulatory submissions including product-specific Technical Documentation assessments (EU Regulations), Design Dossier reviews (EU Regulations).
- Project Management: Provide project management for NAFTA-based customers; Facilitate the issuance of quotes; Coordinate with other TÜV SÜD America personnel (Account Executives, Project Coordinators, Service Line Managers) to handle a variety of audit projects and other client requests.
Requirements:
- Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field.
- 3 years of experience in an industrial medical device environment in Product Design, Product Development, or Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products.
- At least 1 year of experience with quality management-related activities, such as design control, process/product/method validation, design transfer, risk management, manufacturing controls, or QC testing.
Apply online at https://www.tuvsud.com/en-us/careers or send resume to: Dennis Moore, Manager, Talent Acquisition, TÜV SÜD America Inc.
-
Medical Device Audit Lead
4 weeks ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeMedical Device Audit LeadJob Summary:The Medical Device Audit Lead will perform medical device audits in accordance with applicable regulations and standards. This role requires a strong understanding of medical device regulations, quality management systems, and auditing principles.Key Responsibilities:Audit medical devices to ensure compliance with...
-
Medical Device Audit Lead
4 weeks ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeMedical Device Audit LeadThe Medical Device Audit Lead will oversee the performance of medical device audits in accordance with applicable regulations and standards. Key responsibilities include:Auditing: Conduct regulatory audits of clients per Medical Device Regulations (IVDR, MDR); Medical Device Single Audit Program (MDSAP); international quality system...
-
Medical Device Audit Manager
2 weeks ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeMedical Device Audit ManagerOverview:TÜV SÜD is seeking a highly skilled Medical Device Audit Manager to join our team. As a key member of our audit department, you will be responsible for performing medical device audits in accordance with applicable regulations and standards.Job Summary:Perform regulatory audits of clients per Medical Device Regulations...
-
Lead Auditor for Medical Device Quality
4 days ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeMedical Device Lead Auditor OpportunityWe are seeking a skilled Lead Auditor for Medical Device Quality to join our team at TÜV SÜD America Inc. in Wakefield, MA.About the Role:This is a challenging opportunity to leverage your expertise in auditing and quality management in an industrial medical device environment. You will perform regulatory audits of...
-
Senior Medical Device Auditor
2 weeks ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeJob Summary: We are seeking a highly skilled Medical Device Lead Auditor to join our team at TÜV SÜd. As a Medical Device Lead Auditor, you will be responsible for performing medical device audits in accordance with applicable regulations and standards.Key Responsibilities:Perform regulatory audits of clients per Medical Device Regulations (IVDR, MDR);...
-
Medical Device Compliance Specialist
2 days ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeJob OverviewThe Medical Device Compliance Specialist will be responsible for ensuring that medical devices meet regulatory requirements. This role involves auditing clients' facilities to ensure compliance with relevant regulations and standards.Key ResponsibilitiesAudit clients' facilities to ensure compliance with Medical Device Regulations (IVDR, MDR),...
-
MHS Lead Auditor Position
3 weeks ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeMHS Lead Auditor Job OverviewThe MHS Lead Auditor will be responsible for conducting medical device audits in accordance with relevant regulations and standards. This role requires strong knowledge of medical device regulations, quality management systems, and auditing techniques.Key ResponsibilitiesAuditing: Perform regulatory audits of clients per Medical...
-
Auditing and Compliance Manager
2 days ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeJob DescriptionWe are seeking a highly skilled Auditing and Compliance Manager to join our team. The successful candidate will be responsible for auditing clients' facilities to ensure compliance with relevant regulations and standards.ResponsibilitiesAudit clients' facilities to ensure compliance with Medical Device Regulations (IVDR, MDR), Medical Device...
-
Regulatory Affairs Lead
2 days ago
Wakefield, Wakefield, United Kingdom TÜV SÜD Full timeRegulatory Affairs Lead Job SummaryWe are seeking a highly experienced Regulatory Affairs Lead to join our team. The successful candidate will be responsible for ensuring that medical devices meet regulatory requirements and providing project management for NAFTA-based customers.Key ResponsibilitiesAudit clients' facilities to ensure compliance with Medical...
-
Child Health Medical Specialist
3 days ago
Wakefield, Wakefield, United Kingdom Triple West Medical Full timeThis is an exciting opportunity for a Child Health Medical Specialist to join our team at Triple West Medical. As a Specialty Doctor in Paediatrics (CESR Programme), you will be responsible for contributing to the development of our Paediatrics department and providing expert care to neonates and children.Key ResponsibilitiesSome of your key responsibilities...
-
Audit Lead
3 weeks ago
Wakefield, Wakefield, United Kingdom CohnReznick Full timeJob Title: Assurance ManagerCohnReznick is a leading Professional Services and Business Advisory firm that fosters innovation and collaboration in everything we do. We're currently seeking a dedicated Assurance Manager to join our team in our Wakefield Office for virtual and in-office roles.Responsibilities:Lead client engagements and take responsibility for...
-
Estates Officer
1 month ago
Wakefield, Wakefield, United Kingdom NHS Full timeJob Title: Estates Officer - Medical Decontamination SpecialistThe Mid Yorkshire Teaching NHS Trust is seeking a skilled Estates Officer to join their team as a Medical Decontamination Specialist. This is a permanent position, 37.5 hours per week, working from Monday to Friday 08.00 am to 16.00 pm and will be on call 1 in 3 weeks, 7 days per week.Main...
-
Maternity Service Medical Director
3 days ago
Wakefield, Wakefield, United Kingdom Mid Yorkshire Teaching Hospitals NHS Trust Full timeAbout UsMid Yorkshire Teaching Hospitals NHS Trust is a leading healthcare provider in the region, delivering high-quality care and support to over one million people in Wakefield and Kirklees. Our mission is to provide excellent patient outcomes, while continuously striving for innovation and excellence.Job OverviewWe are seeking an exceptional Maternity...
-
Acute Stroke Care Lead
2 days ago
Wakefield, Wakefield, United Kingdom Triple West Medical Full timeJob Title: Acute Stroke Care LeadWe are recruiting an experienced Acute Stroke Care Lead to join our team at Triple West Medical. In this critical role, you will be responsible for ensuring high-quality patient care and leading the stroke service team.Key Responsibilities:Develop and implement evidence-based guidelines for stroke careCollaborate with...
-
Wakefield, Wakefield, United Kingdom https:www.energyjobline.comsitemap Full timeJob Title: Medical Diagnostic Systems Field Service EngineerJob Summary:We are seeking a highly motivated and customer-focused Field Service Engineer to join our team. As a Field Service Engineer, you will be responsible for the service and breakdown repair of sophisticated medical and laboratory diagnostics systems used in pathology departments, NHS...
-
Wakefield, Wakefield, United Kingdom Triple West Medical Full timeAre you an experienced Medical Oncologist looking for a long-term locum opportunity? We have an exciting role based in Yorkshire, working within an amazing team at a highly reputable hospital. This 12-month position offers a competitive salary and the possibility of extension.About the Role:This is a Consultant-level role within the NHS, providing expert...
-
Stroke Medicine Specialist
2 days ago
Wakefield, Wakefield, United Kingdom Triple West Medical Full timeWe are seeking a highly skilled Stroke Medicine Specialist to join our esteemed team at Triple West Medical. The ideal candidate will have a strong background in acute stroke care and rehabilitation medicine.In this rewarding role, you will be responsible for providing high-quality patient care, maintaining professional standards, and assuming teaching...
-
Paediatrician Specialist
2 days ago
Wakefield, Wakefield, United Kingdom Triple West Medical Full timeWe are seeking a highly skilled Paediatrician Specialist to join our team at Triple West Medical. This is an exciting opportunity for a Senior Doctor in Paediatrics to contribute to the development of our Paediatrics department.Job DescriptionThis is a full-time Specialty Doctor in Paediatrics (CESR Programme) role with an estimated annual salary of £80,000...
-
Senior Audit Manager
1 month ago
Wakefield, Wakefield, United Kingdom CohnReznick Full timeCohnReznick is seeking a highly skilled Assurance Manager to lead our audit teams in the Wakefield Office. As a key member of our Advisory, Assurance, and Tax services, you will be responsible for pre-engagement planning, execution, and final deliverables. Your expertise in audit software, such as ProSystem Fx, will be valuable in this role.Key...
-
Audit Manager
4 weeks ago
Wakefield, Wakefield, United Kingdom CohnReznick Full timeJob OpportunityCohnReznick is seeking a highly skilled Audit Manager to join our team in the Wakefield Office. As a key member of our Assurance team, you will be responsible for leading client engagements, developing engagement work plans, and managing a team of staff associates.ResponsibilitiesLead client engagements and develop detailed engagement work...