Product Assessor - Soft Tissue Team

About the Role

As a Product Assessor, one's day-to-day activities will include reviewing technical files, assessing the design and manufacturing processes of medical devices, and ensuring that these devices comply with relevant standards and regulations. The role requires not only a deep understanding of medical devices and their applications but also the ability to work closely with cross-functional teams, including manufacturers, regulators, and other stakeholders.

The Soft Tissue Team at SGS focuses on a wide range of medical devices, from implants and surgical instruments to wound care products and diagnostic equipment. The team's work is pivotal in supporting the development and deployment of life-changing medical technologies. As part of this team, the Product Assessor will play a key role in evaluating the safety, efficacy, and performance of these devices, ensuring they meet the highest standards of quality and regulatory compliance.

What You Will Do

• Conduct comprehensive technical file reviews of medical devices to ensure compliance with relevant regulations and standards.
• Assess the design, manufacturing, and testing of medical devices to verify their safety and efficacy.
• Communicate effectively with manufacturers, suppliers, and other stakeholders to resolve any issues related to device compliance.
• Support CE marking activities and other regulatory processes as required.
• Develop and maintain technical documentation related to product assessments.
• Collaborate with internal teams, including quality assurance, to ensure consistent application of regulatory requirements.
• Provide training and guidance to junior staff members on regulatory requirements and product assessment procedures.
• Participate in audits and inspections as necessary to ensure compliance with regulatory requirements.
• Stay updated on changes to regulatory requirements and industry standards, adapting assessment processes accordingly.
• Engage with external bodies, such as regulatory agencies, to stay informed about industry developments and best practices.

What We Are Looking For

• Extensive experience in the healthcare industry, particularly in areas related to medical devices, such as design, manufacturing, regulation, auditing, or research.
• Specific experience with Cardiovascular and Soft Tissue devices is highly desirable.
• A degree or equivalent qualification in a relevant discipline, such as medicine, pharmacy, engineering, or other related sciences.
• Strong knowledge of medical device regulations, including MDR, MDD, and UKCA.
• Experience with conducting technical file reviews for medical devices.
• Excellent communication and interpersonal skills, with the ability to work effectively in a global team environment.
• Proficiency in written and verbal English, with the ability to prepare and review technical documents.
• In-depth knowledge of relevant medical device categories, including non-active soft-tissue and other implants, and non-active non-implantable devices.

Nice to Have

• Experience working with or for a Notified Body or other certification organization.
• Knowledge of quality management systems, such as ISO 13485.
• Familiarity with clinical trial design and management.
• Experience with regulatory affairs, including interaction with regulatory agencies.
• Certification in a relevant field, such as regulatory affairs or quality management.

Benefits and Perks

• The opportunity to work with a global leader in the medical device industry.
• Competitive salary and benefits package.
• Flexible working arrangements, including remote work options.
• Comprehensive training and development programs to support career growth.
• Access to cutting-edge technologies and innovative medical devices.
• Collaborative and dynamic work environment with a team of experienced professionals.
• Opportunities for international travel and collaboration with global teams.

• Ensure your portfolio includes examples of technical file reviews and regulatory assessments you've conducted in the past.
• Develop a strong understanding of the current regulatory landscape for medical devices, including recent changes to MDR and UKCA.
• Practice explaining complex technical information in a clear, concise manner, as this is a key skill for product assessors.
• Prepare to discuss your experience with specific types of medical devices, particularly those related to soft tissue.
• Consider obtaining certifications in regulatory affairs or quality management to enhance your candidacy.
• Be ready to provide specific examples of how you've handled challenging regulatory issues in the past.
• Highlight any experience you have with quality management systems, such as ISO 13485, and how you've applied these in previous roles.