Complaints Specialist (contract)

Company: NeuMoDx/Qiagen
Location: Ann Arbor
Posted on: January 15, 2022

Job Description:

The Complaints and Vigilance (Contract) will be responsible for monitoring and assessing complaints for reportability, and preparing necessary documentation for regulatory reporting as required.--He/she will also monitor and help organize field correction activities, including regulatory requests and customer responses.
Responsibilities:

• Reviews and assesses complaints for reportability to regulatory authorities (FDA and ex-US).
• Monitors complaint trends and recommends corrective actions as appropriate.
• Plays a key role in controlling and monitoring distributed product, and recalled product through closure of field corrective actions.
• Other responsibilities as assigned and relevant to Associate's competencies or training.
  Qualifications:
  • BA/BS/MS, in scientific or engineering discipline, prefer Life Science, IVD or Medical Device discipline.
  • A minimum of 3 years' experience in an FDA regulated industry preferred.
  • Working knowledge of complaint investigations and medical device reporting requirements.
  • Working knowledge of 21CFR820 and ISO 13485:2019.
  • Proven experience in IVD industry is a strong plus.
  • Demonstrated experience working with cross-functional groups (R&D, Operations, Clin/Reg, etc.) requiring strong interpersonal skills, excellent communication skills, and the ability to work well under pressure.
  • Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation is a must.

Keywords: NeuMoDx/Qiagen, Ann Arbor , Complaints Specialist (contract), Other , Ann Arbor, Michigan