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Clinical Project Leader - EU MDR

Apply Now Job ID R-326235 Date posted 02/01/2019

Job Description Summary

Job Description

Reporting to the Group Leader, Medical Affairs (MA)- Product Lifecycle Management (PLM), Acquisition and Point of Care Platforms, BD Life Sciences – Preanalytical Systems (PAS), this position has the overall responsibility to define and lead the implementation of Medical Affairs requirements for the EU Medical Device Regulation (MDR) and MEDDEV 2.7/1 revision 4 to ensure the safety and efficacy requirements for current and proposed products. 

The EU MDR Clinical Project Leader (CPL) will drive and implement the strategy for PAS Medical Affairs approach to compliance to EU MDR.  The CPL will be part of the EU MDR team and will ensure 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 role will collaborate with other functional and cross-functional associates (Regulatory, Quality, etc.) to ensure smooth and complete alignment of processes related to EU MDR, adverse event reporting, post market surveillance, Post Market Clinical Follow Up and other EU MDR activities.
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.

Responsibilities:

  • Development and implementation of MA strategy and project plan to ensure compliance with the EU MDR regulations.
  • Effectively communicate EU MDR Medical Affairs strategy, metrics, and project status expectations with team members, stakeholders and Sr. Management in a timely and professional manner.
  • Serve as a PAS MA representative 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.
  • Partner with key stakeholders (Regulatory, Quality, etc.) to ensure clear and appropriate alignment of EU MDR strategy.
  • Identify opportunities for efficient work practices and continuous improvement that would support the business unit EU MDR activities (i.e. identify and manage vendor for clinical activities, literature searches, etc.)
  • Prepares Clinical Evaluation Reports compliant to current regulations under the new EU MDR and MEDDEV 2.7/1 Rev 4
  • Leads Post Market Surveillance efforts, gathering vigilance data, literature searches, etc. in support of CERs.
  • Creates or updates Clinical evaluation plan and appropriate templates
  • Creates or updates Post Market Clinical Follow-up Plan and appropriate templates
  • Develops the Post Market Clinical Follow-up Report
  • Preparation of Periodic Safety and Update Report
  • Additional responsibilities:
    • Serve as MA representative on cross functional project teams, who are responsible for the overall development, manufacturing, and marketing of new and modified products.
    • Develops and implements the safety and efficacy requirements and a clinical test plan to address Safety & Efficacy, Regulatory and Marketing requirements for new and improved products and gains functional approval of such.
    • Design clinical, feasibility, Safety & Efficacy studies, and Human Factors Studies.
    • Reviews, interprets and presents medical/scientific data and study results, and technical literature.

Requirements:

  • BS required, preferably in a health-related field, MS or PhD desirable.
  • Working knowledge of EU MDR, Med Dev Rev 4; ISO 62366-1, GCP/ICH required
  • Experience with Clinical Evaluation Report, Post Market Clinical Follow-up Plan and Post Market Surveillance is required.
  • Experience in the areas of clinical trials (study design, statistics, technical writing) is required
  • 3+ years of experience in clinical laboratory or clinical research/product development is required; experience in a medical device/IVD company is a plus.
  • 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.
  • Advance knowledge of quality system and other relevant U.S. and international medical device regulations is a plus.
  • 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.
  • MT (ASCP) or equivalent is desirable.

**This position does not offer relocation assistance**

    Primary Work Location

    USA NJ - Franklin Lakes

    Additional Locations

    Work Shift

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