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Specialist, Clinical Customer Advocacy - Entry Level

Apply Now Job ID R-349621 Date posted 10/16/2019

Locations

San Diego, California

Job Description Summary

Responsible for the completion of all tasks associated with management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations. Preparation of FDA/Regulators Additional Information (AI) requests associated with the event reporting.

Job Description

Duties & Responsibilities

  • Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability.
  • Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products.
  • Write and submit eMDR reports to the FDA in strict adherence with regulatory requirements and timelines; performs MDR searches/queries.
  • Write and submit MDPR reports to Health Canada in strict adherence with regulatory requirements and timelines; performs MDR searches/queries.
  • Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information.
  • Maintain complaint and MDR file documentation in accordance with regulatory requirements. Completes global complaint handling and adverse event reporting activities related to BD products.
  • Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies.
  • Comply with the site Quality System.
  • Performs other duties as assigned.

Qualifications

  • HS degree required, Bachelor degree preferred
  • A minimum of 1 to 3 years experience in Quality, Regulatory or Complaint management; or equivalent combination of education and experience
  • Working knowledge of QA, Regulatory Affairs in a medical device industry required
  • Able to utilize computers for development of reports and summary of project experience including word processing, graphics and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel
  • Prior work with TrackWise Complaint Handling System preferred, not required 
  • Prior experience filing eMDRs preferred, not required 
  • Ability to work on multiple projects with various disciplines are essential.  Position requires innovative thinking, ability to solve problems and meet deadlines

Position requires being able to work a staggered shift as needed: ability to work Saturday, Sunday, Days, Evenings if needed. Does offer 40 hours per week.

Primary Work Location

USA CA - San Diego TC Bldg C&D

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