Job Description: Summary
As BD's Corporate Regulatory Operations (Reg Ops) Manager, you'll provide direction and project management execution to one of BD's most complex and global initiatives having C-Suite impact and visibility.
The Regulatory Operations Manager would report to the Senior Director of Regulatory Operations and would oversee execution of various projects across BD's ten (10) business units to achieve objectives related to regulatory compliance deadlines in the EU. Additionally, this role would assist in the implementation of new technologies to improve Regulatory's product master data management capabilities. This position will need to take complex ideas and translate them into easy to understand information to all levels of the organization.
This position would be based in BD's Corporate Headquarters in Franklin Lakes, New Jersey and would require domestic and international travel on occasion.
This position is through 9/30/2022. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BD.
Responsible for engaging with 10 Business Units to drive follow up action items and prioritization against monthly goals related to the EU MDR and PIM projects
Responsible for managing RAID (Risk, Assumptions, Issues, Decisions) log across Reg Ops Projects
Responsible for planning and consolidating content for key stakeholder meetings and workshops
Responsible for creating product master data governance processes related to product life cycle change control
Responsible for partner with other global regulatory project leaders to align communications and timelines ensuring regional and business unit stakeholders are kept informed
Responsible for assisting work-stream leads create/maintain milestone charts and work breakdown structures
Responsible for leading the organizational change management associated with portions of the EU MDR and PIM initiatives
Bachelor's degree; any discipline
6 years working experience in the in the life sciences industry (Medical Device, Pharma, Biotech)
3 years working experience in Regulatory Affairs/Operations, or Quality
2 year managing direct reports and small project teams
Excellent written and verbal communication, especially presentation and facilitation skills
Demonstrated ability to lead, mentor, and develop others
Detail-oriented and analytical with the ability to prioritize, plan, and organize across work-streams
Knowledge of and an interest in master data management principles and applications
Demonstrated deep understanding of project, risk, and communications management
Regulatory Affairs Certification (RAC)
Project Management Professional Certification (PMP)
Lean Six Sigma Certification (Green Belt)
Information Technology Infrastructure Library Foundations Certification (ITIL)
Knowledge of the European Medical Device Regulation (EU MDR)
Experience deploying a Product Information Management (PIM) system or Master Data Management (MDM) system
Advanced degree in business or science related discipline
Primary Work Location
USA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)