Technical Manager
Descrizione dell'offerta
Position: Technical Director - Medical Devices (Regulation (EU) 2017/745)
Location: Remote (with regular coordination meetings on-site and/or remotely)
Type: Full-time
About Certexe
Certexe is a newly founded Italian company, headquartered in Italy, working towards designation as a CE Notified Body under MDR and IVDR. Joining us at this stage means stepping in at the foundation phase, where your leadership will not only guide accreditation but also shape the long-term structure and strategy of the organization. We offer competitive compensation, flexibility, and the rare chance to grow with a Notified Body from start-up to international recognition.
About the Role
We are seeking an experienced and highly skilled Technical Director to lead our Technical Department for Medical Devices Regulation (EU) 2017/745 (MDR). This is a strategic leadership role with full responsibility for driving the accreditation process as a Notified Body and, once accredited, managing certification activities and technical operations.
Key Responsibilities
• Act as Head of the Technical Department for MDR, leading all activities related to the accreditation process and ensuring full technical compliance with applicable regulations.
• Oversee the drafting, preparation, and submission of technical documentation required for the accreditation application.
• Act as primary liaison with the Quality Manager, Management Team, and Technical Department, ensuring coordination, consistency, and efficiency.
• Support the executive team in the selection, evaluation, and qualification of technical personnel involved in MDR certification activities.
• Ensure the qualification and ongoing competence of all technical personnel in accordance with applicable regulatory and quality standards.
• After accreditation, lead and coordinate the technical department and certification activities, ensuring timely and compliant assessments and decision-making processes.
• Ensure compliance with all key horizontal harmonized standards including ISO 13485, ISO 14971, ISO/IEC 17020, and ISO/IEC 17021.
• Drive the continuous improvement and alignment of technical processes, ensuring best practices in conformity assessment.
Requirements
• University degree in Engineering, Chemical Sciences, Pharmacy, or related field.
• Minimum 4 years of professional experience with a medical device manufacturer or 2 years as a Technical Expert or Scheme Manager within a Notified Body.
• Solid knowledge of Regulation (EU) 2017/745, its conformity assessment procedures, and associated technical documentation.
• Proven understanding of key standards including:
o ISO 13485
o ISO 14971
o ISO/IEC 17020
o ISO/IEC 17021
• Direct experience in the accreditation process under MDR is a strong advantage.
• Strong leadership, problem-solving skills, and intellectual flexibility.
• Proficiency in Italian and English (spoken and written).
Highly Desirable
• Qualification as assessor or technical expert for the evaluation and assessment of medical devices in one or more of the following device codes:
o MDA: 0203, 0204, 0305
o MDN: 1202, 1203, 1204, 1208, 1209, 1211, 1212, 1213
o MDS: 1001, 1005, 1008, 1009, 1010, 1011, 1012
• Previous participation in the MDR accreditation process of a Notified Body.
We Offer
• A rare chance to join at the foundation phase of a Notified Body and directly shape its future.
• A senior leadership position with high visibility and real impact across the organization.
• Competitive salary and benefits designed to attract top-tier professionals.
• A flexible, mainly remote work model with opportunities for international collaboration.
• The stability of experienced founders combined with the excitement and growth potential of a new venture.
• Long-term career growth as Certexe evolves into a fully accredited, internationally recognized Notified Body.