Product Assessor - Soft Tissue Team

About the Role

The role is remote, allowing for flexibility and the opportunity to work with a global team. You will be part of a network of 2,600 offices and laboratories, working together to achieve SGS's mission.

What You Will Do

• Conduct comprehensive assessments of Cardiovascular and Soft Tissue products to ensure compliance with applicable regulations.
• Ensure technical file reviews are technically sound and adhere to the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices.
• Support CE marking activities carried out by SGS.
• Contribute to the training and qualification of junior staff, including the creation of training materials.
• Communicate effectively with team members and clients regarding product assessments.
• Work to minimize risks associated with medical device certification and maintenance.
• Review and analyze technical documentation to identify any discrepancies or areas of concern.
• Collaborate with cross-functional teams to ensure that all aspects of product assessment are covered.
• Stay updated with the latest regulatory requirements and industry standards.

What We Are Looking For

• Extensive experience in healthcare products or related activities, such as design, manufacturing, regulation, auditing, or research.
• Specific experience in the design, manufacture, testing, or use of Cardiovascular and Soft Tissue devices is required.
• Experience conducting Cardiovascular and Soft Tissue Product Assessments for another Certification/Notified body (Technical File reviewer) is advantageous.
• Degree or equivalent qualification in a relevant discipline such as medicine, pharmacy, engineering, or other related sciences.
• Strong communication skills, especially through electronic mediums.
• Proficiency in written and verbal English, as reports will be reviewed and queried in English.
• In-depth knowledge of medical devices within the non-active categories as per Commission Regulation 2017/2185.

Nice to Have

• Experience with regulatory requirements beyond the EU, such as FDA regulations in the US.
• Knowledge of quality management systems such as ISO 13485.
• Familiarity with auditing principles and practices.
• Certification in a related field, such as regulatory affairs or quality assurance.

Benefits and Perks

• The opportunity to work with a global leader in testing, inspection, and certification.
• Remote work arrangement for a better work-life balance.
• Professional development opportunities, including training and qualification programs.
• Collaborative and dynamic work environment.
• Competitive compensation package.
• Access to a network of professionals in the medical device industry.

• Ensure your resume highlights specific experience with medical device regulations, particularly MDR and UKCA.
• Prepare examples of how you've handled complex technical file reviews and ensured compliance.
• Familiarize yourself with SGS's approach to testing, inspection, and certification to show your interest in the company's mission.
• Be ready to discuss your experience with remote collaboration tools and how you maintain productivity in a remote work environment.
• Consider creating a portfolio that showcases your technical writing skills, especially in creating training materials or reports.
• Research the current market rate for Product Assessors and be prepared to negotiate your salary based on your experience and qualifications.