Product Assessor for Orthopaedic (Notified Body)

Posted Yesterday
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Hiring Remotely in București, ROU
In-Office or Remote
Mid level
Information Technology • Professional Services • Security • Consulting
The Role
Conduct technical and clinical assessments of Class IIa, IIb, and III orthopaedic medical devices for EU MDR and UK MDR compliance. Review technical documentation, identify regulatory deviations, support CE and UKCA marking, communicate assessment findings, manage scheduled deliverables, and train junior staff. The role requires orthopaedic device design, manufacturing, testing, auditing, or research experience, strong written English, and knowledge of applicable medical device standards and regulations.
Summary Generated by Built In
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

As a Product Assessor, you will play a pivotal role in conducting orthopaedic product assessments and technical documentation reviews in strict adherence to European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and for Class IIa/IIb and/or Class III devices.

Key Responsibilities:

  • Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant commission regulation codes, with potential to extend expertise to dental devices.
  • Identify and rectify instances where device technical documentation deviates from compliance with applicable requirements.
  • Provide support for CE and UKCA marking activities within SGS.
  • Contribute to the training and qualification of junior staff and develop comprehensive training materials.
  • Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimise regulatory risks associated with medical device certification.
  • Ensuring diligent management of scheduled work to maintain timeliness and efficiency in deliverables.

Qualifications

We are seeking an experienced candidate with:

  • 4+ years of professional experience in the orthopaedic products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, a minimum of two years should be directly involved in the design, manufacturing, and testing of orthopaedic products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies.
  • Understanding of essential standards for orthopaedic products.
  • Prior experience in conducting orthopaedic product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous.
  • A Master's degree, PhD, or equivalent in a related discipline, such as medicine, biomedical engineering, or biomedical science, preferably with a focus on orthopaedic devices.
  • Proficiency in modern electronic communication platforms.
  • Strong written English skills essential for reviewing and querying Technical Documentation assessment reports.
  • Demonstrated ability to learn independently.
  • Desirable: Regulatory Acumen - knowledge of the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and familiarity with medical device codes MDA/MDN/MDS for MDR as outlined in Commission Implementing Regulation (EU) 2017/2185.

Additional Information

Why SGS?

  • Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
  • Enjoy a flexible schedule and work model.
  • Access SGS University and Campus for continuous learning options.
  • Thrive in a multinational environment, collaborating with colleagues from multiple continents.
  • Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. 

Please share your CV in English. The role is fully remote. People from other countries can apply as well. 

Skills Required

  • At least 4 years of professional experience in the orthopaedic products sector or a related field, including design, manufacturing, auditing, or research
  • At least 2 years of direct experience in the design, manufacturing, and testing of orthopaedic products, or equivalent deep understanding of their underlying scientific principles
  • Understanding of essential standards for orthopaedic products
  • Master’s degree, PhD, or equivalent qualification in medicine, biomedical engineering, biomedical science, or a related discipline
  • Strong written English skills for reviewing and querying technical documentation assessment reports
  • Proficiency with modern electronic communication platforms
  • Ability to learn independently
  • Prior orthopaedic product assessment experience with a certification or notified body
  • Knowledge of EU MDR 2017/745 and UK MDR 2002
  • Familiarity with MDA, MDN, and MDS medical device codes under Commission Implementing Regulation (EU) 2017/2185

SGS Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about SGS and has not been reviewed or approved by SGS.

  • Healthcare Strength Core medical, dental, and vision coverage is part of the U.S. package and is generally viewed as adequate even if not standout. Company information also underscores healthcare coverage as a standard element of the offering.
  • Retirement Support A 401(k) is commonly included in the U.S., and group disclosures reference post‑employment benefit plans in select regions. These components provide a baseline of retirement security beyond core pay.
  • Strong & Reliable Incentives Annual incentive/bonus structures are part of the compensation mix and cited positively in some regions and roles. Punctual pay is also highlighted as a plus.

SGS Insights

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The Company
HQ: Geneva
99,600 Employees
Year Founded: 1878

What We Do

SGS is the world's leading Testing, Inspection, and Certification company, providing quality and safety control services.

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