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Specialist, Regulatory Operations

Apply Now Job ID R-334840 Date posted 04/10/2019

Job Description Summary

Job Description

As BD’s Corporate Regulatory Operations (Reg Ops) Specialist, you’ll provide data analytics, meeting management, and status reporting support to one of BD’s most complex and global initiatives with have C-Suite impact and visibility.

The Regulatory Operations Specialist would report to the Senior Director of Regulatory Operations and would oversee day-to-day execution of various projects within the department with a strong focus on data collection, data maintenance, and converting the data into business intelligence.  Additionally, this role would assist in the regulatory strategy and decision making related to complying with EU MDR/IVDR by supporting the Regulatory Center of Excellence group in publishing regulatory guidance to all the Business Units.  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 is an assignment position 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. Relocation assistance is not provided.**

Essential Job Responsibilities:

  • Responsible for facilitating the Regulatory Center of Excellence discussion topics to achieve timely decisions and guidance for the business units
  • Responsible for supporting the research/analysis of EU MDR/IVDR topics to support the Regulatory Center of Excellence in accessing regulatory pathways and drafting corporate position papers
  • Responsible for executing product master data governance processes related to product life cycle change control within the new Product Information Management (PIM) system
  • Responsible for engaging with 10 Business Units to drive detailed requirements for BI Reports within the PIM system, and supporting the development and testing of reports
  • Responsible for following up with BUs on data requests needed to support reporting needs
  • Responsible for planning and consolidating content for key stakeholder meetings and workshops
  • Responsible for maintenance of EU MDR/IVDR Corporate SharePoint site

Minimum Qualifications:

  • Bachelor's degree; any discipline
  • 3 years working experience in the in the life sciences industry (Medical Device, Pharma, Biotech)
  • 3 years working experience in Regulatory Affairs/Operations, Compliance, or Quality
  • 1 year managing virtual project teams
  • Detail-oriented and analytical with demonstrated ability to extract insight from data
  • Very strong Microsoft Office Skills, especially Excel and SharePoint

Preferred Qualifications:

  • Advanced Tableau, PowerBI, or Qlik reporting tool skills/certifications
  • Knowledge of the European Medical Device Regulation (EU MDR)
  • Regulatory Affairs Certification (RAC)
  • Project Management Professional Certification (PMP)
  • Experience maintain data quality in a Product Information Management (PIM) system or Master Data Management (MDM) system
  • Interest in regulatory strategy, including regulation interpretation and helping to define corporate BD positions on global compliance topics

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com