Join the GMED team today and work on the frontier of Medical Device Innovation!
Reports to: Unit Manager
Division: Certification
Position classification: Exempt, Full Time
Fields: Medical Devices, Active Medical Devices – Healthcare
Location(s): Rockville, MD or Remote (Home office)
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.
- 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 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!
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