Senior Product Assessor, Active Devices

SGS; Milano; Remoto; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading global certification company is looking for a Senior Product Assessor for Active Medical Devices. This remote role involves managing a team, conducting compliance assessments, and ensuring the highest standards. Candidates should have significant experience in medical devices and relevant technical knowledge. The company promotes innovation and offers a flexible work environment, supporting professional development.

Servizi

Flexible schedule and hybrid model

Continuous learning options at SGS University

Multinational work environment

Benefits platform

Competenze

• Prior experience as a Product Assessor within a Notified Body.
• Minimum four years of professional experience in healthcare products.
• Knowledge of MDA Technical File Codes is mandatory.

Mansioni

• Support and guide a team of Product Assessors.
• Conduct technical documentation reviews for compliance.
• Recruit and onboard new team members.

Conoscenze

Technical documentation review

Team management

Understanding of EN 60601 and related standards

Good written English skills

Active Medical Devices knowledge

Descrizione del lavoro

Are you ready to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD / MDR technical documentation review then we have an exhilarating opportunity for you!

Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices. This role will allow you to make a significant impact in the field of certification.

As a member of our Medical Device team you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices.

The role is remote based and we are open to candidates located everywhere across Europe and India. Candidates must hold a valid work permit for their country of residency.

Your Responsibilities

• Supporting and guiding your team of talented Product Assessors
• Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
• Collaborating with cross-functional teams to increase efficiency and quality
• Monitoring the team's technical competence KPIs and wellbeing and providing feedback and support when there are concerns.
• Recruiting, including reviewing CVs, undertaking interviews and supporting onboarding of new starters
• Developing training and presenting the training to others in SGS or externally as deemed necessary.
• Assisting with technical queries and those related to sales within the Active Medical Devices field.
• Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.

Qualifications

To be eligible for this role you should have prior experience as a Product Assessor / Specialist / Technical File Reviewer within another Notified Body for active devices conducting reviews against MDD and / or MDR.

Eligibility and Experience

• Four years of professional experience in the field of healthcare products or related activities such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
• Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand‑alone software devices, etc.) through designing, manufacturing, or testing of such devices;
• Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.;
• Good written English skills (reports will be reviewed/queried in English);
• Knowledge of the following Technical File codes is mandatory (per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0304 & MDA 0314 (MUST HAVE).
• Knowledge of the following Technical File codes would be a great addition (per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0203, MDA 0301, MDA 0302, MDA 0303, MDA 0305, MDA 0306, MDA 308, MDA 0312, MDA 0317.

Please submit your CV in English.

Why SGS

• Global and very stable company, world leader in the TIC (Testing Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS University and Campus for continuous learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us

At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

Remote Work

Yes

Employment Type

Full-time