BD (Becton, Dickinson and Company) Medical Affairs Specialist EU MDR (Remote Optional) in Warwick, Rhode Island
Job Description Summary
The Clinical Affairs Specialist EU MDR is the Post-Market Clinical Follow-Up Medical Affairs process owner and is responsible for ensuring implementation of the Post-Market Clinical Follow-Up (PMCF) Process for Becton Dickinson Interventional Surgery (BDIS).
This position handles multiple product types across the Becton Dickinson enterprise. Creates and finalizes all PMCF plans for BDI Surgery. Along with Global Clinical Development, supports the creation of PMCF Study protocols. Documents the outcomes of the PMCF studies into Clinical Evaluation Reports (CERs). Supports the compilation of PMCF Evaluation Reports in conjunction with Marketing. Ensure that any required Safety Reporting to the Notified Bodies is performed.
This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2023.
Track and ensure progress of all EU MDR projects where Medical Affairs involvement is required.
Develop new or provide input to existing metrics to appropriately monitor and communicate project statuses for BDIS Medical Affairs.
Author new or modified procedures to address opportunities for improvement.
Track project status, establish deadlines, and identify required resources for Medical Affairs activities in coordination with BDIS EU MDR program manager and the BDIS VP, Medical Affairs.
Proactively identify issues and create mitigation strategies in collaboration with BDIS EU MDR program manager and cross-functional project team members.
Coordinate, attend and generate meeting minutes for BDIS Medical Affairs team meetings (e.g., face-to-face, teleconference, and/or webinars).
Drive decisions and strategy determination where required with input and direction from MA leadership.
Develop high quality and compliant PMCF plans in cooperation with Medical Affairs leadership, including schedules and project timelines, to satisfy regulatory requirements.
Assist in analysis of clinical Post Market Surveillance data for completeness, safety and performance.
Generate and summarize Post Market Surveillance data necessary for PMS and PMCF reports.
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.
Clinical research experience in a medically regulated and technical environment.
Demonstrated project oversight or clinical trial management skills or relevant certifications.
Ability to work as a project leader and influence others.
Strong interpersonal skills in the areas of verbal and written communications, customer focus, organizational and time management, and team collaboration.
Strong information management, listening and assessment skills.
Strong analytical thinking, questioning and problem-solving skills.
Ability to prioritize 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.
MS required,preferably in the life sciences, clinical or other relevant technical areas and a minimum of 2 years clinical trial or project oversight experience.
2+ years’ experience in the Medical Device, and/or other regulated industry (Pharma, IVD).
Basic knowledge and understanding of 21 CFR 803, ISO14155, and MEDDEV.
Recent proven success within a product development core/extended team highly desired.
Occasional travel possible for training or educational/scientific conferences, but not required.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. a strong drive for results.
Primary Work LocationUSA RI - Warwick
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.