Senior Product Assessor, Active Devices

SGS Australia; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global leader in testing and certification is seeking a Senior Product Assessor for Active Medical Devices. As a member of our Medical Device team, you will oversee a team of Product Assessors, ensuring compliance with EU regulations. Ideal candidates will have four years in healthcare product review, strong knowledge of MDD/MDR, and excellent English writing skills. The role supports a flexible hybrid model, allowing for significant professional impact across Europe and India.

Benefits

Flexible schedule

Hybrid work model

Continuous learning options

Global work environment

Benefits platform

Qualifications

• Four years of experience in healthcare product review.
• Experience with Active Medical Devices.
• Knowledge of EN 60601 and similar standards.

Responsibilities

• Support and guide a team of Product Assessors.
• Conduct technical documentation reviews.
• Collaborate with cross-functional teams.
• Monitor technical competence and KPIs.
• Conduct recruitment and training for new assessors.

Skills

Technical documentation review

Compliance with EU regulations

Leadership and team management

Excellent written English skills

Knowledge of MDD/MDR

Job description

Company Description

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 codes is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0304 & MDA 0314 (MUST HAVE).
• Knowledge of the following Technical File code is would be a great addition (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0203, MDA 0301, MDA 0302, MDA 0303, MDA 0305, MDA 0306, MDA 0308, 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.