Senior Product Assessor, Active Devices

SGS; Lisboa; Híbrido; EUR 50 000 - 70 000; Tempo integral

Resumo da oferta

A global testing and certification company based in Lisbon seeks a Senior Product Assessor for Active Devices. In this role, you'll manage a team and conduct essential technical documentation reviews for medical devices, ensuring compliance with EU standards. Candidates should have extensive knowledge of Active Medical Devices and relevant regulations. Flexible work schedules and a supportive environment are offered.

Serviços

Flexible schedule

Continuous learning options

Benefits platform

Qualificações

• Four years of professional experience in healthcare products or related activities.
• Two years in design, manufacture, testing, or use of the device.
• Thorough knowledge of EN 60601, EN 62304, EN 62366.

Responsabilidades

• Guide team of Product Assessors.
• Conduct technical documentation reviews.
• Collaborate with cross-functional teams.
• Monitor team's technical competence and wellbeing.
• Conduct recruitment and develop training.

Conhecimentos

Active Medical Devices knowledge

Good written English skills

Knowledge of related standards

Technical documentation review

Descrição da oferta de emprego

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

Job Description

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.

It is remote based, and we are open to candidates located everywhere across Europe and India. But they must hold a valid work permit for their country of residency.

Your Responsibilities Will Include:

• 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.
• Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters
• Develop training and present the training to others in SGS or externally as deemed necessary.
• Assist with technical queries and those related to sales within the Active Medical Devices field.
• Ensure 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.

Additionally, You Must Possess:

• 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 (as reports will be reviewed/queried in English);
• Knowledge of the following Technical File code is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0314
• Knowledge of the following Technical File codes would be a great addition (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0203, MDA 0301, MDA 0302, MDA 0305, MDA 0306, MDA 0312, MDA 0317

Please submit your CV in English.

Additional Information

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 continuos 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.