BD (Becton, Dickinson and Company) Regulatory Project Manager in Franklin Lakes, New Jersey
Job Description SummaryThe Regulatory Project Manager is responsible for the leadership and execution of moderate to high complexity regulatory projects with considerable resources within BD Medical – Medication Delivery Solutions
Determine and discern detailed requirements on larger scale regulatory projects (e.g. euMDR) 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.
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.
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 MDS Business Groups and BDX.
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 7 years of experience working in medical device industry or equivalent 2-5 years of regulatory affairs experience
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 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.
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
- FDA 21 CFR Part 820, ISO 13485
Primary Work LocationUSA NJ - Franklin Lakes
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