Product Assessor - Cardiovascular and Soft Tissue

## About the Role As a Product Assessor at SGS, you will play a crucial role in ensuring the compliance and safety of medical devices, specifically focusing on Cardiovascular and Soft Tissue products. Your expertise will be invaluable in conducting comprehensive assessments, reviewing technical files, and ensuring all regulatory requirements are met. This is a unique opportunity to work with a global leader in testing, inspection, and certification, contributing to a safer and more interconnected world.

The role requires a deep understanding of medical device regulations, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices. Your work will involve meticulous review and assessment of products to ensure they adhere to these stringent standards, minimizing risks associated with medical device certification and maintenance.

As part of the SGS team, you will also be involved in supporting CE marking activities, contributing to the training and qualification of junior staff, and communicating effectively with team members and clients regarding product assessments. This role demands not only technical expertise but also strong communication and interpersonal skills, particularly in a remote work setting.

## What You Will Do - Conduct comprehensive assessments of Cardiovascular and Soft Tissue products to ensure compliance with all applicable requirements.

• Review technical files to guarantee adherence 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, ensuring all processes are in line with regulatory standards.
• Contribute to the training and qualification of junior staff, including the creation of training materials to enhance team capabilities.
• Communicate effectively with team members and clients regarding product assessments, providing clear, concise information on the assessment process and outcomes.
• Collaborate with internal stakeholders to ensure that product assessments are technically sound and compliant with relevant regulations.
• Identify and mitigate risks associated with medical device certification and maintenance, providing recommendations for improvement.
• Stay updated on the latest developments in medical device regulations and technologies, applying this knowledge to improve assessment processes.
• Develop and maintain strong relationships with clients, providing excellent customer service and support throughout the assessment process.
• Participate in internal audits and compliance activities to ensure the highest standards of quality and integrity.

## 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.
• Experience conducting Cardiovascular and Soft Tissue Product Assessments for another Certification/Notified body is highly 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, with proficiency in written and verbal English.
• In-depth knowledge of medical devices within the specified non-active categories.
• Ability to work independently in a remote setting, with strong time management and organizational skills.
• Proficiency in digital tools and platforms used for remote collaboration and assessment processes.

## Nice to Have - Experience with quality management systems and audit processes.

• Knowledge of other regulatory frameworks beyond MDR, MDD, and UKCA.
• Certification in a related field, such as quality assurance or regulatory affairs.
• Experience in training or mentoring junior staff.

## Benefits and Perks - The opportunity to work with a global leader in testing, inspection, and certification.

• Competitive salary and benefits package.
• Flexible, remote work arrangement with access to digital tools and platforms.
• Professional development opportunities, including training and certification programs.
• Collaborative, dynamic work environment with a team of experts.
• Access to a global network of professionals in the medical device industry.
• Recognition and reward for outstanding performance and contributions to the company.

- Ensure your CV and cover letter are tailored to the specific requirements of the Product Assessor role, highlighting relevant experience and skills.

• Develop a strong understanding of the latest medical device regulations, including MDR, MDD, and UKCA, to stand out as a candidate.
• Prepare examples of your experience in conducting product assessments and ensuring regulatory compliance.
• Familiarize yourself with digital tools and platforms used for remote collaboration and assessments to demonstrate your ability to work effectively in a remote setting.
• During the interview, be ready to discuss your approach to risk mitigation and quality assurance in medical device certification and maintenance.
• Consider obtaining or highlighting any relevant certifications, such as those in quality assurance or regulatory affairs, to enhance your application.