Main Purpose of Role
- Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639.
- This role ensures the effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management.
- Oversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives.
The role reports to the Head of Notified Body 1639.
Key Accountabilities
The role encompasses a wide range of responsibilities, including but not limited to the following:
- Lead and manage technical functions: clinical, auditors, products assessors, for all medical schemes, globally.
- Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles.
- Ensure the team follows efficient allocation and utilization of technical resources across all conformity assessment activities (in coordination with Commercial & Delivery).
- Operational management of technical certification activities, including resource allocation, technical KPI monitoring, and process improvements.
- Lead training and competence management strategies across technical teams to maintain regulatory and technical expertise.
- Support proactive recruitment, onboarding, and qualification of personnel involved in conformity assessment.
- Drive continuous improvement of technical workflows, IT systems supporting assessment, and quality management processes to enhance efficiency and service quality.
- Act as key interface with regulatory authorities, accreditation bodies, and internal stakeholders to maintain SGS reputation, designations, accreditations and compliance.
- Monitor and respond to regulatory changes, industry trends, and accreditation requirements to ensure proactive adaptation of technical operations.
- Manage and promote impartiality and conflict of interest policies across all teams (including subcontractors), ensuring independence of conformity assessment decisions.
- Ensure compliance with SGS integrity policies, health & safety standards, and confidentiality across technical operations.
- Foster a culture of client focus, integrity, and continuous development within technical teams (while maintaining impartiality and regulatory rigor).
- Collaborate with Commercial & Delivery to harmonize handovers (contract鈫抪lanning鈫抋ssessment), align capacity with demand, and support timely service without compromising compliance.
- Provide strategic input into designation maintenance and regulatory engagement, coordinating technical evidence, metrics, and remediation plans as required.
- Commercial/Delivery Touchpoints carried over for completeness (scoped to technical dependencies):
- Provide technical input to commercial business development and bid responses when needed (e.g., feasibility, scope, technical risk, assessor profiles).
- Support budget/KPI visibility for technical operations and contribute to overall performance management.
Skills & Knowledge
- Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD.
- Proven and solid leadership in managing cross-functional teams in regulated environments.
- Knowledge of conformity assessment procedures and QMS requirements.
- Excellent interpersonal and stakeholder management skills.
- Strong organizational and change management capabilities.
- Strong commercial understanding and appreciation of the TIC industry.
- Experience in resource planning.
- Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR.
- Qualification as Final Reviewer and Decision Maker under MDR or IVDR.
- Experience in a Notified Body or equivalent regulatory organization.
Experience
Essential
- Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment.
- At least 5 years senior leadership in a Notified Body managing technical employees.
- Minimum 2 years in revenue-focused leadership roles, including full profit and loss (P&L) accountability, budget management, and financial reporting.
- Demonstrated success in P&L role.
- Demonstrated success in leading high-performing teams and driving operational efficiency, with a track record of delivering measurable, positive organizational impact.
- Fluency in English in addition to the local language.
Desirable
- Given the complex network internal interactions of this role, experience gained within the SGS Group would be an advantage.
Qualifications
- University degree in medicine, engineering, life sciences, or a related field.
The role can be fully remote and we are open to consider candidates located accros Europe (with valid work permit). Please kindly write your CV in English