Product Assessor / Senior Product Assessor - Active Devices

SgsSgs·Remote(Anywhere in the World)·Work From Anywhere
Other

WFA Digital Insight

The demand for skilled product assessors in the medical device industry is on the rise, with a 25% increase in job openings in the past year alone. As a senior product assessor at SGS, you'll be at the forefront of ensuring the safety and efficacy of active medical devices. With the EU's MDR regulations in place, companies are looking for experts who can navigate complex technical documentation and compliance requirements. SGS, a global leader in testing and certification, offers a unique opportunity to work with a talented team and make a significant impact in the industry. Before applying, candidates should be aware of the need for strong technical expertise, excellent communication skills, and the ability to work in a fast-paced, remote environment.

Job Description

About the Role

As a Senior Product Assessor at SGS, you will be responsible for conducting thorough technical documentation reviews of active medical devices, ensuring compliance with EU regulations and standards. You will work closely with a team of talented product assessors, providing guidance and support to ensure the highest level of service delivery. Your expertise will be crucial in enabling SGS to provide certification services to medical device manufacturers, ultimately contributing to the development of safer and more effective medical devices.

The role entails working remotely, collaborating with cross-functional teams, and managing a small team of product assessors. You will be responsible for diving deep into the exciting world of active medical devices, including monitoring equipment, therapeutic devices, and devices utilizing radiation. Your strong background in product assessment, combined with your knowledge of EU regulations and standards, will make you an invaluable asset to the SGS team.

What You Will Do

  • Conduct technical documentation reviews of active medical devices to ensure compliance with EU regulations and standards
  • Manage a small team of globally based product assessors, providing guidance and support
  • Collaborate with cross-functional teams to increase efficiency and quality
  • Monitor the team's technical competence, KPIs, and wellbeing, providing feedback and support when necessary
  • Develop and present 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 the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through efficient service delivery
  • Support recruitment, including reviewing CVs, undertaking interviews, and onboarding new starters
  • Develop and maintain knowledge of the latest EU regulations and standards, including MDD and MDR

What We Are Looking For

  • Prior experience as a product assessor/specialist/technical file reviewer within another notified body for active devices
  • Four years of professional experience in the field of healthcare products or related activities, including design, manufacturing, auditing, or research
  • Strong knowledge of active medical devices, including monitoring equipment, therapeutic devices, and devices utilizing radiation
  • Thorough knowledge and understanding of related standards, including EN 60601, EN 62304, and EN 62366
  • Good written English skills, as reports will be reviewed and queried in English
  • Knowledge of Technical File codes, as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185

Nice to Have

  • Experience working with medical devices, including design, manufacturing, or testing
  • Knowledge of EU regulations and standards, including MDD and MDR
  • Experience with team management and leadership
  • Strong communication and interpersonal skills

Benefits and Perks

  • Opportunity to work with a global leader in testing and certification
  • Collaborative and dynamic work environment
  • Professional development and growth opportunities
  • Flexible remote work arrangement
  • Access to cutting-edge technology and tools
  • Competitive compensation package
  • Comprehensive benefits package, including health insurance and retirement plan
  • Paid time off and holidays
  • Remote stipend and home office setup support

How to Stand Out

  • Develop a strong understanding of EU regulations and standards, including MDD and MDR, to increase your chances of success in this role
  • Highlight your experience working with technical documentation and compliance requirements in your application and during interviews
  • Showcase your leadership and team management skills, as well as your ability to work in a fast-paced, remote environment
  • Familiarize yourself with SGS's services and values to demonstrate your knowledge and enthusiasm for the company
  • Prepare to discuss your experience with active medical devices, including monitoring equipment, therapeutic devices, and devices utilizing radiation
  • Be prepared to provide specific examples of your technical expertise and problem-solving skills during the interview process

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