Join the LNE/G-MED team today
and work on the frontier of Medical Device Innovation!
Location(s): USA, Canada or Europe
Contract Type: Perm Full-Time or per mission
Fields: Medical Device – Healthcare
Salary: Competitive Salary
About G-MED North America, Inc
G-MED NA is the North American subsidiary of the National Metrology and Testing Laboratory, LNE, a leading Certification Body established in 1901. We serve the Medical Device Industry with offices in Europe and the United States. Our goal: Provide the best in Product Certification and Quality Management Services for Medical Device Manufacturers worldwide.
In addition to our CE marking, ISO 9001:2015, ISO 13485:2016 and MDSAP certification services, LNE/G-MED is accredited by the Standards Council of Canada SCC under the Canadian Medical Devices Conformity Assessment System CMDCAS and is an Authorized Organization for the Medical Device Single Audit Program MDSAP. Our full range of technical conformity services, from Diagnostic audits to Training services, allows the convenience and efficiency of a local based team of Technical Experts, Assessors, Auditors and Certification Program Managers.
LNE/G-MED North America is an Equal Employment Opportunity. For the US, we offer excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, a company paid life insurance, paid holidays and time off.
About the CER expert
Practicing Medical Doctors and Physicians serve as Clinical Expert assessing Medical Device Manufacturer’s Clinical Evaluation Reports based on Clinical Literature and /or Clinical Investigational Data. They have an important role in the approval process for Medical Devices by virtue of their extensive knowledge of Clinical Trial Design and evaluation of results. LNE/G-MED is looking to fill Clinical Expert Positions in a variety of medical specialties. Positions are available throughout the various units at LNE/G-MED and include: Active Implantable Medical Device (AIMD), Medical Device with Animal Origin (MDAO), Active Medical Device (AMD) etc.
These medical specialties include but are not limited to:
• Cardiology: heart and vascular diseases (coronary heart and artery conditions, heart failure, cardiac arrhythmia, valvular heart diseases, cardiopulmonary disorders, blood vessel diseases, other cardiovascular conditions)
• Orthopedics: musculoskeletal trauma affecting body's muscles (joints reconstruction, ligaments, tendons, and nerves) and skeleton (hand and upper extremity, foot and ankle; shoulder and elbow; spine and scoliosis; hip and knee), degenerative musculoskeletal diseases or infections (arthritis).
• Gynecology & Obstetrics: reproductive endocrinology, contraceptive, perinatology, gynecologic oncology, and/or pelvic surgery.
• Wound care: Wound Care, Hyperbaric medicine, Advanced Wound Healing, Limb Preservation, Tissue Transfer and Flaps, Skin Grafts.
• Nanomedicine: use of nanoparticles in Medical Device Technologies
The successful candidate will comply with LNE’s procedures, processes, policies in regard to Clinical Evaluation and conduct:
• Medical Device Clinical Evaluation Report (CER) reviews including Clinical Investigation Protocols and Reports, review of Post Market Surveillance (PMS) Data, Post Market Clinical Follow Up (PMCF) data etc.
• Assessment of technical/engineering aspects for medical device technologies (active medical devices, non-active medical devices, implantable medical devices, drug combined medical devices, medical devices with animal origins) in relation to their safety and efficiency.
• Review of the adequacy of clinical data provided with the Instruction for Use (IFU) and Risk Management file for Medical Devices under the following European Medical Devices Directives: Medical Devices 93/42/EEC (MDD), Active Medical Device Implantable 90/385/EEC (AIMD)
About the candidate’s profile
• Doctor of Medicine (MD) or Doctor of Osteopathy (DO) (currently practicing or practicing within the past 5 years)
• Degree: Doctor of Medicine (MD) or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States, Canada or Europe.
• Extensive knowledge and experience in the diagnosis and treatment of a wide range of diseases / conditions relating to one or more medical specialties.
• Comprehensive knowledge of the state of the art for the procedures involved in the diagnosis and treatment of specific medical conditions.
• Outstanding critical thinking and analytical skills in particular for clinical data evaluation: Lecture and analysis of Clinical data, soundness of clinical study rationale and protocol, adequacy of design, and feasibility,
• Knowledge of clinical trials regulations and guidelines
• Excellent written and verbal communication skills with ability to summarize clinical content for specific audiences
• Knowledge in Bio-statistics ( ability to perform stat reviews for clinical trial datasets)
• Must be literate in the use of MS Office applications
• Preferred knowledge of the European Medical Devices Directives
• Result oriented : Demonstrated ability to prioritize and focus on deadlines
• Fluent in English ( French or Spanish is a plus)
• Authorized to work in the US for US positions
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts together with a resume.