Product Reviewer

GMED; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K retirement plan

Annual bonus

Telework option

Job summary

GMED North America, the US subsidiary of GMED, is seeking an Evaluator/Reviewer to perform CE marking conformity assessments across medical devices. You will review design dossiers and technical documentation to verify compliance with applicable EU directives and regulations, delivering comprehensive reports to support or reject CE certification.

The role requires coordinating with internal experts, leading training sessions, and staying updated on regulatory changes while contributing to a

Qualifications

• University degree in medicine, pharmacy, engineering or other relevant sciences.
• 4 years of professional experience in healthcare products or related activities.
• 2 years shall be in the design, manufacture, testing, or use of the device or technology to be assessed.

Responsibilities

• Conduct CE type and CE design dossier/product review evaluations for different device classes.
• Coordinate with reviewers, clinical and process experts to meet review timelines and ensure report quality.
• Participate in standardization, technical, and regulatory workshops or events.
• Ensure regulatory monitoring and communication within the team on new requirements.
• Provide pedagogical responsibility and lead training sessions or technical days.
• Performs other duties as required or delegated.

Skills

Regulatory review

CE marking

Cross-functional collaboration

Technical writing

Training & mentoring

Education

University degree in medicine/pharmacy/engineering or related field

Job description

Join the GMED team today and work on the frontier of Medical DeviceInnovation!

Reports to: Unit Manager

Division: Certification

Position Classification: Exempt, Full-Time

Fields: Medical Devices, In-Vitro Diagnostics - Healthcare

Location(s): Rockville, MD or Remote (Home office)

Job Description

As part of your mission as an evaluator/product reviewer, you will be responsible for carrying out evaluations as part of the CE marking conformity assessment procedures in the field of medical devices. You will be responsible for reviewing the design dossiers / technical documentation independently or as a team of evaluators for a range of medical devices with the goal of verifying whether the devices meet the requirements of the relevant standards/regulation. The deliverable will be comprehensive review reports which either support or reject the manufacturer's application for CE marking based on the evidence provided. Ultimately your work will determine whether a device has been demonstrated to be safe and effective, meets its intended use, and can be recommended for CE certification to the notified body.

Essential Functions

• 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.
• Performs other duties and responsibilities as required or requested or delegated.

Who You Are

Required Education and Experience:

• 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.

Who We Are

GMED North America is the US subsidiary of GMED, a leading Certification Organization, 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, GMED certifies a vast range of medical devices and in vitro diagnostic medical devices. An Auditing Organization recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States.

Our goal is to provide the best in Product Certification and Quality Management Services for medical device manufacturers worldwide. At GMED North America, we strive to the highest standards of professionalism, competency, work ethic, and customer service. All our employees are the cornerstone of this process because their work directly influences GMED North America's reputation.

Aside from our expertise with due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the world.

Our Values:

• Commitment to Clients and Patients' safety
• Expertise
• Reliability
• Team Work

GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture. GMED North America recruits, employs, trains, compensates, and promotes regardless of race, religion, sex, national origin, ethnicity, age, disability, pregnancy, political affiliation, sexual orientation, gender identity, color, marital status, veteran status, medical condition, and all the other characteristics that make us unique.

What We Offer

At GMED North America, our primary goal is to attract and retain exceptional talent who are not only subject matter experts, but also passionate about upholding the integrity and excellence of our services. We recognize that our success is driven by the expertise and commitment of our team, and we are focused on creating an environment where top professionals can thrive.

GMED North America offers a full and competitive benefits package including group-sponsored health, dental, and vision coverage, flexible spending accounts, short-term and long-term disability, company-paid life insurance, competitive base salary, annual bonus based on company performance, and a 401K retirement program. We promote work-life balance through the option to telework, flexible working arrangements, generous time off program, paid holidays, paid bereavement leave, paid parental leave, commuter benefits program for public transportation, and internet stipend.

We offer growth opportunities within the organization. There are a lot of opportunities and employees are able to apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.

Thank you for your interest in GMED North America.

We look forward to hearing from you!