Experienced Medical Device Evaluator/Product Reviewer – CE Marking Conformity Assessment Procedures for Medical Devices and In-Vitro Diagnostics

About Us

GMED North America is a leading Certification Organization and a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n 722/2012 on products utilizing tissues of animal origin. We certify a vast range of medical devices and in-vitro diagnostic medical devices, serving the Medical Device Industry with offices in Europe and the United States.

Job Description

As a Medical Device Evaluator/Product Reviewer, you will play a critical role in ensuring the safety and effectiveness of medical devices and in-vitro diagnostics. You will be responsible for conducting evaluations as part of the CE marking conformity assessment procedures, reviewing design dossiers/technical documentation, and providing comprehensive review reports that support or reject the manufacturer's application for CE marking.

Key Responsibilities

• Conduct CE type and CE design dossier/product review evaluations in the framework of the applicable European Directives and Regulations (CE) for different device classes and for a wide range of medical devices depending on the area of expertise.
• Coordinate with other product reviewers/evaluators, clinical experts, process experts, technical experts, and the certification project managers to meet the review timelines, provide quality review reports, and ensure the consistency of the information via the consolidation of the review/assessment.
• Participate in standardization, technical, and/or regulatory workshops or speaking events.
• Ensure active regulatory monitoring and communication within the team of new requirements identified in your specific areas of medical device expertise.
• Have pedagogical responsibility and the animation of training sessions or technical days.
• Perform other duties and responsibilities as required or requested or delegated.

Who We Are Looking For

We are seeking a highly skilled and experienced Medical Device Evaluator/Product Reviewer to join our team. The ideal candidate will have a strong background in medical devices, in-vitro diagnostics, or a related field, and will possess excellent analytical, communication, and project management skills.

Essential Qualifications

• Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g., medicine, pharmacy, engineering, or other relevant sciences.
• 4 years of professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research.
• Of which 2 years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed.

Preferred Qualifications

• Experience in CE marking conformity assessment procedures and European Directives and Regulations (CE).
• Knowledge of medical device regulations, standards, and guidelines, including ISO 13485, ISO 14971, and IEC 62304.
• Experience with design dossier/technical documentation review and evaluation.
• Strong analytical, communication, and project management skills.
• Ability to work independently and as part of a team.
• Excellent time management and organizational skills.
• Ability to adapt to changing priorities and deadlines.

Skills and Competencies

The successful candidate will possess the following skills and competencies:

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong project management and organizational skills.
• Ability to adapt to changing priorities and deadlines.
• Knowledge of medical device regulations, standards, and guidelines.
• Experience with design dossier/technical documentation review and evaluation.

Career Growth Opportunities and Learning Benefits

At GMED North America, we offer a range of career growth opportunities and learning benefits to support your professional development and success. These include:

• Opportunities for advancement within the organization.
• Training and development programs to enhance your skills and knowledge.
• Mentorship and coaching to support your career growth.
• Access to industry-leading tools and resources.
• Opportunities to participate in industry events and conferences.

Work Environment and Company Culture

GMED North America is a dynamic and innovative organization that values diversity, inclusion, and teamwork. We offer a collaborative and supportive work environment that encourages open communication, creativity, and innovation. Our company culture is built on the following values:

• Commitment to clients and patients' safety.
• Expertise.
• Reliability.
• Teamwork.

Compensation, Perks, and Benefits

We offer a competitive compensation package, including:

• A competitive base salary.
• Annual bonus based on company performance.
• A 401K retirement program.
• Group-sponsored health, dental, and vision coverage.
• Flexible spending accounts.
• Short-term and long-term disability.
• Company-paid life insurance.
• Telework and flexible working arrangements.
• Generous time off program.
• Paid holidays.
• Paid bereavement leave.
• Paid parental leave.
• Commuter benefits program for public transportation.
• Internet stipend.

Conclusion

If you are a highly skilled and experienced Medical Device Evaluator/Product Reviewer looking for a challenging and rewarding career opportunity, we encourage you to apply. We offer a competitive compensation package, a dynamic and innovative work environment, and a range of career growth opportunities and learning benefits to support your professional development and success.

How to Apply

To apply for this exciting opportunity, please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you!