Senior Product Assessor - Active Devices

Company Description

We are delighted that you're thinking about a career with SGS!

As the world's leading testing, inspection, and certification company, we, SGS, provide value to society by enabling a better, safer, and more interconnected world. We sustain global standards across diverse industries, including the consumer products sector.

At SGS, we believe in rewarding our employees for their hard work and commitment. As part of our team, you would be eligible for:

• Performance related bonus (discretionary and subject to eligibility criteria)
• Private medical cover (subject to eligibility criteria)
• Competitive pension scheme + Life Assurance
• Generous Annual Leave allowance (increasing with service) plus bank holidays.
• An additional day off for your birthday
• Discounted Gym Membership
• Retailer Discounts
• Access to electric vehicle leasing scheme (subject to eligibility criteria)
• Enhanced maternity/paternity and adoption pay.
• Length of Service Awards
• Christmas Vouchers
• Health & Wellbeing initiatives

Job Description

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

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.

Your responsibilities will include:

• Supporting and guiding your team of talented Product Assessors
• Conducting thorough technical documentation reviews and ensuring compliance with UK and 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.
• 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 Approved / Notified Body for active devices, conducting reviews against UKAS MDD and/or MDR.
• 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 Technical File codes desirable

Additional Information

APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.