Job Description: SummaryThe Regulatory Project Manager is (RPM) a regulatory specialist with project management capabilities. The RPM is part of MDS Regulatory Process team and works closely with MDS Business Group (BG) regulatory teams to plan, drive and track regulatory deliverables related to larger regulatory programs including but not limited to Bard Cost Synergy; Change to Win and EU MDR.
Establish regulatory deliverables and plans for the projects assigned. Determine the resources and budget needs within MDS RA and communicate the needs and projects to the MDS RA team and leaders.
Track the execution of the projects and develop dashboards and reports for communication up, down and sideways across the organizations.
Point person for establishing and maintaining upcoming changes to the regualtory documentation (e.g. Technical Files) and facilitate the bundling of these changes/submissions due to various programs impacting the registrations. Communicate with platform and BGs to optimize the alignment of submission timing and upcoming changes.
Understand the MDS BG differences and look for opportunities to simplify and align regulatory processes as necessary.
Establish new regulatory processes and formalize existing ones as assigned, contribute to process improvements.
Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify risks, perform required corrective actions, and communicate to all stakeholders.
Serve as a project management subject matter expert, keep Regulatory Affairs leadership abreast of project schedules and potential areas of conflict/concerns or delays.
B.S. degree in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering and regulatory affairs.
LICENSES OR CERTIFICATIONS:
Project Management Certification desired RAC is a plus
4-7 years of experience working in medical device industry or equivalent 2-5 years of working in/with regulatory affairs and general understanding of regualtory affairs Well-versed in program and project management tools and practices Knowledge of quality systems and EU regulatory requirements including the MDD and MDR for medical devices is advantageous
Excellent communication skills Ability to drive the projects without authorities Ability to rapidly build product knowledge and understanding of technical and scientific regulatory activities. Project Management skills Attention to details and organized
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
FDA 21 CFR Part 820, ISO 13485
This position is through 9/30/2020. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BDX
Primary Work LocationUSA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)