Bayer

Data Analyst (Entry) - Data Science - R&D - PH - U...

Job description

DEPARTMENT/TEAM DESCRIPTION

Bayer Radiology Regulatory Affairs Operational Excellence is responsible to ensure global regulatory compliance and active registration status for our medical electro-mechanical (EM), sterile disposable (SD), software and digital products. This team is also responsible for ensuring process efficiencies and day-to-day operations of the Radiology Regulatory Affairs device function.


POSITION SUMMARY

We are looking for a detail-oriented individual who puts compliance at the forefront to join our Radiology Regulatory Affairs team. Candidates must be initially available until mid-November 2022. This position may turn into an extended assignment or a full-time position.


This position will ensure Radiology Regulatory Affairs device staff maintain process compliance. In addition, this individual will collect, upload and maintain medical device master data in global Regulatory databases.


POSITION DUTIES & RESPONSIBILITIES

The Compliance Specialist's primary responsibilities are:

  • Perform periodic audits of the medical device and drug master data in regulatory databases and repositories to ensure data accuracy, completeness, proper revision control and adherence to local/global SOP's
  • Perform periodic audits of medical device labeling in internal and external-facing repositories to ensure adherence to local/global SOP?s and regulations
  • Collect, aggregate, compile, monitor, maintain and report on departmental Key Performance Indicators (KPI)
  • Ensure Regulatory staff is following global Regulatory SOPs and processes through compliance monitoring and the implementation of training initiatives when needed
  • Help identify and support the implementation of process and database improvement initiatives
  • Participates in the assessment and/or implementation of Regulatory IT systems
  • Maintain accurate records and communicate database / project status to teams


A successful candidate will:

  • Have a passion for compliance and organization
  • Be able to manage and effectively analyze large quantities of data
  • Be expected to work well autonomously and as part of a collaborative team
  • Demonstrate interpersonal and communication skills, including an ability to establish good working relationships with diverse individuals
  • Manage time well and prove ability to meet deadlines
  • Be able to work independently and under supervision
  • Have proven communication skills
  • Be proactive in identifying data discrepancies and help resolve them on a timely basis.


REQUIREMENTS/PREFERENCES

  • Minimum 0 - 2 years of experience working in a regulated industry.
  • Bachelor's degree in an IT, Engineering, or Science discipline
  • Experience using Microsoft Office and other information management systems.
  • Previous experience with database management and compliance activities is strongly preferred


This position will be working remotely.


IMPORTANT NOTE for POTENTIAL US CANDIDATES: Our client expects its colleagues to be fully vaccinated against COVID-19. Colleagues are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Our client defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, colleagues are also required to comply with state, local and customer requirements.


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