Global Regulatory Operations Project Specialist
Job Description Summary
The Global Regulatory Operations, Project Specialist, manages and executes Regulatory Operations Workstreams within the Medical Segment that support Global Regulatory Affairs. This position will be a key conduit/liaison between the regions, the Medical Segment and Corporate Regulatory Operations programs to drive training, process support, go live for tool deployment for regions and will be the person responsible for the RIM database for the Medical Segment
- Responsible for the centralization of activities associated with standard regulatory work
- Foster and maintain relationships with the strategic Global Regulatory Affairs organization and other functional partners to ensure understanding of current processes and optimization for BDX processes
- Provide business or regional support for regulatory IT systems; including but not limited to RIM, DMS, eIFU and PIM.
- Owns the movement of transactional activities to a centralized corporate Regulatory Operations function including but not limited to: metrics, monthly reporting, status updates, publishing, renewals, re-registrations and communications, tracking of key RA initiatives.
- Responsible for ensuring effectiveness of implemented harmonized processes through continuous monitoring of compliance.
- Superuser for the RIM data management system for Medical Segment
- Develop and implement training, communication of standard tools, and processes associated with on market support within the Medical Segment
- Establish and manage "user groups" for tools and processes to ensure effectiveness
- Responsible for understanding and executing key change management elements to enable new technology for the Medical Segment
- Able to determine customer pain points, translate into system roadmap or manual work around, build business justification and drive the case for change.
- Maintains appropriate documentation of tasks, project plans, and activities performed
- Based on business needs, helping to translate processes into executable workflows within the regulatory IT systems and tools
- Support corporate change management initiatives and lead change management within RA
- Support centralization of common documentation in support of global registration activities and processes
- Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
- Excellent analytical and problem solving skills
- Experienced in IT systems and business processes to support training and business administration
- Sound working knowledge of the Global regulatory environment
- Ability to effectively communicate complex issues and programs to all levels of the organization.
- Knowledgeable of submission and publishing requirements and tools
- 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
- Project management certification and Lean Six Sigma preferred
- Minimum of 5 years of professional experience or relevant medical device experience with 2 years of relevant Regulatory Affairs, Quality Assurance, or Medical Affairs experience, and process and project management.
- Maintain data, use, process, training of centralized databases including Sharepoint and requirements
- Broad knowledge of the med tech industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.
- 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 development and approval process as well as life cycle maintenance
- Excellent communication skills; both oral and written
- Develop or revise procedures as needed
Essential Job Functions:
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, and intranet sites.
- Able to assess processes to recommend and drive to efficient future state processes including gaining buy in from 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.
Primary Work LocationUSA NJ - Franklin Lakes
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ