Job Description Summary
The Regulatory Project Manager is responsible for the leadership and execution of moderate to high complexity regulatory projects with considerable resources within the BD Interventional Segment.
Determine and discern detailed requirements on larger scale regulatory projects and Cost Synergy Program to establish the project deliverables, and manages changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes.
Develop project plan and timeline.
Establish and maintain team members and project stakeholder relationships, expectations, and communications.
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 up, down and sideways.
Execute and lead the execution of tasks as defined in the project management plan in order to achieve the project goals, and actively manages project risk.
Serve as a project management subject matter expert, keep Regulatory Affairs leadership abreast of project schedules and potential areas of conflict/concerns or delays.
Interface with senior management and support decision-making. Monitor timelines and developing strategies to stay on schedule and navigating through the internal regulatory and global program team governance for projects across BDI business units.
B.S. degree or higher in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering and regulatory affairs.
LICENSES OR CERTIFICATIONS :
Project Management Certification preferred RAC is a plus
- Minimum of 10 years of experience working in medical device industry or equivalent
- 4-7 years of regulatory affairs experience
- Knowledge of international medical device registration requirements, e.g. China, Japan.
- Well-versed in program and project management tools and practices
- Knowledge of quality systems and EU regulatory requirements
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities.
- Project Management skills
- Attention to details and organized.
- 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 Location
USA NJ - Franklin Lakes