Job Description SummaryThe manager of Global Regulatory Operations manages and executes the centralization of key BDX items that support Global Regulatory Affairs.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
- Serves as part of the corporate Regulatory Operations team that drives the strategy for shared services support.
- Skilled at technology such as Sharepoint, Excel, power point, intranet sites.
- Able to assess processes to recommend and drive to efficient future state processes including gaining buy in for key stakeholders
- Assess and provide recommendations of best practices between business units and drive to standardization of processes where possible.
- Lead updates of communications including metrics, newsletters, town halls, and other key communications.
- Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures where appropriate.
- Assist with additional regulatory projects as needed.
- Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
- Excellent analytical and problem solving skills
- Sound working knowledge of the Global regulatory environment
- Ability to effectively communicate complex issues and programs to all levels of the organization.
- Excellent experience and knowledge of PC/database skills
- Experience and knowledge of document management systems
- Proven ability to earn the trust of leaders within the organization, including senior leaders
- Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
- Proven ability to resolve conflict (striving for win-win outcomes)
- Proven ability to deliver tough messages in a professional manner
- Proven ability to act independently and to execute with limited information and ambiguity
Education and/or Experience:
- Bachelor degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
- Project management certification and Lean Six Sigma preferred
- Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Ability to work in a team environment
- Working knowledge of Medical Device and IVD development and approval process as well as life cycle maintenance
- Excellent communication skills; both oral and written
- Minimum of 7 years of professional experience of relevant medical device experience with 4 years of relevant regulatory affairs experience, and process and project management. Broad knowledge of the med tech industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.