Clinical Specialist
4 weeks ago
GMED NA is seeking a highly skilled and experienced Internal Clinician to join our team. As a key member of our clinical evaluation team, you will be responsible for assessing clinical studies of various medical devices, ensuring compliance with European Medical Devices Directives and Regulations, and other applicable regulatory systems.
Key Responsibilities:- Perform thorough assessments of manufacturer's clinical evaluation reports, including equivalence rationales and risk assessments, appropriateness of clinical claims, indications, and contraindications for use, and user information and warnings.
- Review and evaluate clinical data, including endpoints, follow-up, and clinical evaluation data, to ensure compliance with regulatory requirements.
- Develop and maintain expertise in present and pending regulatory requirements, standards, and GMED NA America service capabilities through internal training sessions, external seminars, and reading of scientific articles.
- Provide internal and external training in areas of expertise, including clinical evaluation and data requirements.
- Communicate effectively with internal and external customers, including answering questions, relaying messages, and providing information on standards, regulatory, and technical requirements.
- Doctor in Medicine
- Minimum four years in healthcare 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, with French language knowledge a plus.
- Occasional domestic and international travels up to 20% required.
- Ability to deliver all services within required timescales.
- Experience with analyzing clinical data and working with biostatisticians, as well as experience in clinical trials as a Principal Investigator or team member, is highly desirable.
GMED North America is the US subsidiary of GMED, a leading Certification Organization and Notified Body authorized to act under European Regulation (EU) 2017/745 on medical devices. 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.
We strive to provide the best in Product Certification and Quality Management Services for medical device manufacturers worldwide, upholding the highest standards of professionalism, competency, work ethic, and customer service. Our diverse workforce and commitment to a healthy work environment make us an attractive employer.
What We Offer:- Competitive benefits package, including group-sponsored health, dental, and vision coverage, flexible spending accounts, short-term and long-term disability, company-paid life insurance, and a 401K retirement program.
- Flexible working arrangements, generous time off program, paid holidays, paid bereavement leave, paid parental leave, commuter benefits program for public transportation, and internet stipend.
- Growth opportunities within the organization, with numerous success stories and a commitment to employee development.
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