When you need to be sure
Global Team Leader – IVDR
Location
United Kingdom
Posted
83 days ago
Salary
0
Seniority
Senior
Job Description
Global Team Leader – IVDR
SGS
• In conjunction with Global Head of Certification and compliance and QA & RA Manager, liaise with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions. • Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams, relating to in vitro diagnostic medical device certification, as well as the respective medical device scheme managers (ISO13485, MDSAP, UKCA). • Lead the team of IVDR product assessors and IVDR IHC. • Support the Training and Competency Manager and CV reviewer in conformity assessment and CV review. • Develop, update and maintain appropriate training packages for IVDR Product Assessors within the in vitro diagnostic medical device conformity assessment process in collaboration with Training and competences manager. • Manage the in vitro diagnostic medical device training process for both existing and new IVDR Product Assessors and IVDR IHC within the in vitro diagnostic medical device conformity assessment process. • Provide technical advice to support all stages of the in vitro diagnostic medical device conformity assessment process in collaboration with IVDR FR & CDM Team Leader. • Develop, maintain and implement QMS documentation related to in vitro diagnostic medical devices conformity assessment process of SGS NB 1639 with QA & RA Manager, aligned with best practices (e.g. MDCG guidance documents) and applicable regulatory and accreditation requirements. • Establish competence criteria for Technical Experts. • Approval of mirror reviews for IVDR Product Assessors related to IVDR qualification and requalification requirements. • Manage the development and implementation, including approval process for and IVDR Product Assessors and IVDR IHC (new personnel & for ongoing monitoring and re-approval of personnel). • Contribute to the day-to-day management and business development of the in vitro diagnostic medical devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance.
Job Requirements
- Extensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical documentation assessment techniques.
- Effective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues.
- Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents.
- Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices.
- Knowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria.
- The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
- Experience of management of cross functional global teams is an asset.
Benefits
- Flexible schedule and remote model
- SGS university and Campus for continuos learning options
- Multinational environment where you will work with colleagues from multiple continents
- Benefits platform
Related Guides
Related Categories
Related Job Pages
More General Jobs
Early Intervention Service Coordinator
Autism SpeaksAutism Speaks enhances lives today and is accelerating a spectrum of solutions for tomorrow.
• Help families of children with a developmental delay navigate all aspects of the Early Intervention (EI) system • Coordinate all services available to children across agencies • Provide information on available services, resources, and options • Provide case management to families by planning, coordinating, participating, and monitoring the Individualized Family Service Plan (IFSP) • Communicate and assess families' concerns, priorities, resources, strengths, and needs • Ensure services are provided as per the Individual Family Service Plan (IFSP) • Assist families to access community resources and services • Complete notes after each contact made • Submit paperwork on a timely basis • Communicate with child’s EI team including providers, outside agencies, municipality, and ACP-EI staff
• Conduct comprehensive autism assessments for adults via telehealth • Deliver actionable feedback to clients following evaluations and develop personalized post-assessment plans • Write clear, thorough clinical reports that document findings and recommendations • Participate in case consultations and clinical collaborative opportunities • Focus on direct client care while we handle administrative tasks and insurance billing
• Tracking and coordinating assigned day-to-day activities for output channels, including writings.stephenwolfram.com, arXiv and Google Scholar • Coordinating with internal and external subject matter experts and research assistants to edit and implement material written by Stephen Wolfram • Coordinating and executing assigned executive-initiated writing projects and other content-creation activities, including blog administration • Interacting with cross-functional teams, including company executives, graphic design and product development teams • Managing and maintaining author profiles across academic and professional platforms • Managing multiple projects simultaneously • Being available during nontraditional work hours for reactive editorial duties • Researching and gathering information from disparate sources and media types • Performing other administrative tasks as requested
• Building your own agency • Full control over your own agenda • Supported by a team of Territory Managers • Generating leads with appointments booked in for you • Incentives for self-generated leads • Diverse revenue streams from referrals • Setting your own commission rates • Running your own business with flexible hours • Employing your own team • Access to in-house marketing support and training




