Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): North Bethesda, MD or Remote (Home office)
Reports to: Unit Manager
Department: Certification Department
Position classification: Exempt, Full Time
Fields: Medical Devices, Active Medical Devices – Healthcare
Ref: MD-GMED-115-21-10
JOB DESCRIPTION
GMED NA is looking for an approachable and outgoing individual who will work closely with
our medical device customers. Your role and responsibilities include assessment of clinical
studies of various medical devices type per the European Medical Devices Directives and
Regulations, other applicable Regulatory Systems and International standards.
ESSENTIAL FUNCTIONS
Your responsibilities will include, but are not limited to:
File Reviews: Perform assessment of manufacturer´s clinical evaluation reports, of medical
devices (various types such as implants e.g. hip implants, stents, cages, active implantable
medical devices) including:
• Equivalence rationales and risk assessments
• Appropriateness of clinical claims, indications and contraindications for use, and user
information and warnings
• Adequacy of endpoints, follow-up and clinical evaluation data
• Adequacy of post market clinical follow up provision and follow up
Expertise: Keep abreast of present and pending regulatory requirements, standards and GMED
NA America service capabilities through internal training sessions, external seminars, and
reading of scientific articles. Help to develop internal “best practice” guides for clinical evaluation
and data requirements within your specialism.
Provide internal and external training in areas of expertise
Customer Service: Communicate in a courteous and effective manner with internal and external
customers in all circumstances including answering questions, relaying messages, and providing
information with regard to standards, regulatory and technical requirements for compliance with
standards and the respective regulatory system.
Project Management: Project management potentially consists of selling clinical services,
coordinating multiple projects and answering client and colleagues’ questions.
WHO YOU ARE
Required Education and Qualifications:
• Doctor in Medicine
• Minimum four years in health care services or related sectors including;
• Minimum of two years: In usage, development or testing/evaluation of medical devices or
in clinical study or clinical evaluation of such devices
• Excellent knowledge of spoken and written English language. French language knowledge
is a plus.
• Occasional domestic and international travels up to 20% are required.
• Deliver all services within required timescales and to a high quality
You’ll ideally have experience with analyzing clinical data and working with biostatisticians
and have experience in clinical trials either as a Principal Investigator or a team member.
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 and 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
WHAT WE OFFER
We offer a competitive benefits package including group-sponsored health, dental and vision
coverage, short-term and long-term disability, 401k plan, company-paid life insurance, paid
holidays and time off program providing our employees with great work-life balance. 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.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse,
inclusive, and healthy work environment with a unique culture.
You are strongly encouraged to submit your resume and cover letter.
We look forward to hearing from you!
