Technical Manager

Certexe; Savona; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A medical device regulatory organization is seeking a Technical Director to lead the accreditation process under Regulation (EU) 2017/745. This role requires strong leadership and regulatory knowledge, with a background in engineering or sciences. The position offers competitive compensation, flexibility, and long-term career growth opportunities as the organization evolves into a fully accredited body.

Servizi

Competitive salary

Flexible work model

Opportunity for international collaboration

Long-term career growth

Competenze

• Minimum 4 years of professional experience with a medical device manufacturer or 2 years as a Technical Expert.
• Solid knowledge of Regulation (EU) 2017/745 and conformity assessment procedures.
• Direct experience in the accreditation process under MDR is a strong advantage.

Mansioni

• Act as Head of the Technical Department for MDR, leading accreditation activities.
• Ensure full technical compliance with applicable regulations.
• Oversee drafting and submission of technical documentation for accreditation.

Conoscenze

Leadership

Problem-solving

Regulatory knowledge

Proficiency in Italian

Proficiency in English

Formazione

University degree in Engineering, Chemical Sciences, Pharmacy, or related field

Descrizione del lavoro

Overview

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.

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 ISO 13485, ISO 14971, ISO/IEC 17020, 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: MDA 0203, 0204, 0305; MDN 1202, 1203, 1204, 1208, 1209, 1211, 1212, 1213; 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.