The position reports to the Head of Delivery & Operations
Main Purpose of Role
- In conjunction with Global Head of Certification and compliance and QA & RA Manager, liase 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 Manage 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 on-going 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.
Key Accountabilities
- Maintain a full knowledge and understanding of SGS (Global System and SGS NB 1639) procedures, Best Practices Guides, MDCG Guidance Documents and external approval criteria to allow efficient and effective technical reviews.
- Liaise with the Medical Devices Segment Management Team to be aware and understand (emerging) developments in European regulations, procedures, methodologies and tools with respect to in vitro diagnostic medical devices.
- Provide technical support and staff training to all parts of the SGS NB 1639 conformity assessment process to enhance the service capability of the business and clients in the in vitro diagnostic medical devices area
- Support business development activities as required (e.g., including follow up and/or referral of enquiries, sales visits, assistance at events, seminars) to enable on-going growth of the in vitro diagnostic medical device business.
- Support in the recruitment, assessment and approval process of in-vitro diagnostic medical device auditors and product assessors to ensure adequate resource is available to meet operational and business targets
- Develop external training packages for clients by providing regulatory advice and guidance within the scope of notified body.
- Support the achievement of in vitro diagnostic medical devices operational and financial targets.
- Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.
- Ensure full compliance with the Company’s Code of Integrity and Secrecy and Non-Disclosure Agreement.
- At all times adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.