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Medical Affairs Specialist EU MDR Full-time

at Becton Dickinson & Company in Rhode Island (Published at 31-01-2019)

Job Description Summary


Job Description

The Medical Affairs Specialist EU MDR Post-Market Clinical Follow-Up Medical Affairs process owner, ensures implementation of the PMCF Process for Becton Dickinson Interventional (BDI)/Surgery.


This covers multiple product types across the Becton Dickinson enterprise. Creates and finalizes all PMCF plans for BDI Surgery. Along with Global Clinical Development, support the creation of PMCF Study protocols. Documents the outcomes of the PMCF studies into Clinical Evaluation Reports (CERs). Support the compilation of PMCF Evaluation Reports in conjunction with Marketing. Ensure that any required Safety Reporting to the Notified Bodies is performed. Approves all PMCF plans, protocols and reports.


Responsibilities:

  • Ensure CERs are updated to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR and BDI SOPs.
  • Work with Post Market Surveillance team to meet the requirements in generating PMS and PMCF reports.
  • Develop high quality and compliant PMCF plans to satisfy regulatory requirements and maintain internal timelines.
  • Interpret and critically analyze clinical and Post Market Surveillance data for completeness, safety and efficacy.
  • Proficiently generate and extract Post Market Surveillance data necessary for creating PMS and PMCF reports.
  • Collaboratively work with a cross-functional team on the EU MDR requirements and reports to be submitted.
  • Provide clinical study support for internal and external audits and inspections.
  • Identify product characteristics and/or failures that could affect risk analysis plans.
  • Assist Post Market Surveillance team and internal Complaints staff as necessary.
  • Utilize creative problem solving techniques to address clinical challenges from regulatory bodies.

Education/Experience:

  • MS in a technical discipline or equivalent education, experience, training.
  • 2+ years? experience in the Medical Device, and/or other regulated industry (Pharma, IVD).
  • Basic knowledge of 21 CFR 803, ISO14155, MEDDEV, GHTF SG5-N2R8
  • Ability to query data/analyze data.
  • Analytical skill and focus on detail.
  • Proven cross-functional teamwork and skills.
  • Utilize creative problem solving techniques.
  • Clinical research experience in a medically regulated and technical environment.
  • Demonstrated strong organization skills.
  • Must be able to work under pressure to meet process/project time frames and company requirements.
  • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
  • Able to exercise sound judgment using standard operating procedures and policies to determine appropriate action to achieve objectives.
  • Strong written communication skills.

Primary Work Location

USA RI - Warwick

Additional Locations


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