Staff Regulatory Affairs Specialist

 •  Becton Dickinson and San Jose, CA

5 - 7 years experience  •  Medical Equipment

Salary depends on experience
Posted on 11/22/17
5 - 7 years experience
Medical Equipment
Salary depends on experience
Posted on 11/22/17

Job Description

The Staff Regulatory Affairs (RA) Specialist is responsible for establishing and maintaining regulatory operating systems and databases, performing change control assessment, reviewing/approval product labeling, and conducting training.  He/she is responsible for assisting Sr. Director of Regulatory Affairs to ensure department processes and procedures related to regulatory responsibilities are compliant, current and efficient.

Job responsibilities:

  • Maintains, updates and creates (when deemed necessary) Regulatory department procedures and databases.
  • Acts as the main Regulatory contact to assess impacts of product and process changes to registrations worldwide. 
  • Reviews and approves product labeling.
  • Leads regulatory training.
  • Assists in the preparation and submission of regulatory documents.
  • Monitors FDA, EU and other agency laws, regulations, and standards changes associated with BDB products, and communicates the changes to Regulatory leadership.
  • Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.
  • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in regulatory topics.
  • Performs other duties and assignments as required.

Minimum Qualifications:

Education and Experience:

  • Minimum B.S. degree in life science field (molecular biology, biology, microbiology, chemistry, etc.). M.S. and/or Ph.D. a plus.
  • Project management certifications or regulatory/quality certifications (RAC, CQA, CQM, etc.) encouraged.
  • Minimum of 5 years directly applicable regulatory experience (regulatory system set-up, maintenance, change controls, label review, etc.) in an IVD or medical device company.

Minimum knowledge and skills:

  • Familiar with IVD or Medical device regulatory systems.
  • Demonstrated strong organizational and planning skills, including action oriented, focused urgency and driving for results
  • Demonstrated self-starter, learning agility, multitasking skills, and positive attitude.
  • Demonstrates excellence in both oral and written communication within the department, between functional groups, and externally.  Prepares formal written reports/documents for distribution within and external to the department. 
  • Fosters collaboration among team members.
  • Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint)

Job ID R-18049

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