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|Job Category :
||GForce Life Sciences
||EU MDR Clinical Project Leader (CPL)
|Job Description :
||The EU MDR Clinical Project Leader (CPL) will act as an extended MA EU MDR team member and will provide support to the MA EU MDR Core Team Member in ensuring compliance of the medical and clinical activities related to EU MDR. Additionally, this role will provide medical, scientific, and technical leadership and perspective to project teams and other functions such as Regulatory and Quality.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
Duties / Expectations of Role
o Support MA EU MDR Core Team Member in the implementation of MA strategy and project plan to ensure compliance with the EU MDR regulations.
o Support the Medical Affairs EU MDR Core Team Member on the EU MDR implementation team to ensure business compliance and appropriate Medical Affairs representation as well as provide feedback to the functional activities related to EU MDR.
o Assist in the identification of opportunities for efficient work practices and continuous improvement that would support MA EU MDR activities (i.e. identify and manage vendor for clinical activities, literature searches, etc.)
o Prepare Clinical Evaluation Reports compliant to current regulations under the new EU MDR and MEDDEV 2.7/1 Rev 4
o Support Post Market Surveillance efforts, gathering vigilance data, literature searches, etc. in support of CERs.
o Create or update Clinical Evaluation Plan and appropriate templates
o Create or update Post Market Clinical Follow-up Plan and appropriate templates
o Develop the Post Market Clinical Follow-up Report, as applicable
o Preparation of Periodic Safety and Update Report
o Design clinical, feasibility, Safety & Efficacy studies, and Human Factors Studies.
o Review, interpret and present medical/scientific data and study results, and technical literature.
Mandatory RequirementsBS required, preferably in a health-related field, MS desirable.
Strong interpersonal, communication skills (verbal, presentation, written) and computer skills.Demonstrated experience working in global cross functional teams.Experience in project management.Experience with specimen collection products.Working knowledge of EU MDR, MEDDEV Rev 4; ISO 62366-1, GCP/ICH.Regulatory experience with products commercialized globally as well experience interfacing with external regulatory agencies and notified bodies.Knowledge of scientific methodologies and clinical laboratory science.
Nice to Have Requirements
MT (ASCP) or equivalent is desirable. Knowledge of FDA and Notified Bodies
Knowledge of quality systems and other relevant U.S. and international medical device regulations is a plus. Experience with Clinical Evaluation Report, Post Market Clinical Follow-up Plan and Post Market Surveillance is desirable. 3+ years of experience in clinical laboratory or clinical research/product development; experience in a medical device/IVD company is a plus. Experience in the areas of clinical trials (study design, statistics, technical writing) is desirable.
Term & Start 5 mo contract with possible extension Remote work is a possibility, NJ
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