The Project Manager will be a member of a consulting team, working directly with leadership, managers, and individual contributors to plan and execute projects that focus on global compliance for medical device products. The focus of this role is to identify the emerging regulatory issues relevant to labeling, across several portfolios acquired in acquisition.
- Updates team members immediately following procedures regarding issues or problems requiring follow-up.
- Manage a matrix of programs with well-defined plans and flexible deliverable methodologies to integrate new and changing device regulations enabling product regulatory compliance.
- Create and manage project plans, strategies, timelines and budgets to track progress and hold assigned resources accountable.
- Interface with a variety of management levels and subject matter experts to drive decisions on significant matters, often requiring the coordination of activity across functional groups.
- Maintain project plans to ensure business and project objectives are met.
- Solve issues through information exchange, influence and active persuasion to gain cooperation of other functions on program objectives.
- Lead in the understanding and awareness of global regulatory requirements to ensure compliance. Disseminate and provide guidance and continuing education, as applicable
- Bachelor’s Degree in Business, Engineering, or a technical discipline
- 5+ years of medical device and work experience in regulatory affairs and/or quality assurance with a Bachelor’s Degree;
- 1+ years of cross-functional project management experience.
- Demonstration of Interpersonal skills and critical thinking, with the ability to interact with all levels in an organization.
- The ability to convey complex information appropriate to the clinical situation/setting in a high stress environment.
- The ability to lead and influence teams without direct supervision.