Quality Assurance Analyst
at BioTalent
in
Oakland,
California
Posted in Other 3 days ago.
Type: full-time
Job Description:
Quality Assurance Analyst EU-MDR Post-Market Regulation (EU) 2017/745Responsibilities:
- Manage manufacturing batch records/DHRs using eQMS with Technical Operations and an overseas Contract Manufacturer.
- Handle medical device complaints and vigilance reports per US FDA and EU MDR; experience with other MDSAP regions preferred.
- Manage and report on CAPAs; collaborate with CAPA owners; chair monthly CAPA meetings.
- Work with EU MDR entities (Competent Authority, Notified Body, Importer/Distributor, Authorized Representative).
- Administer EUDAMED, FDA GUDID, and GTIN databases.
- Write EU-MDR Post Market documentation (PMSP, PSUR, Trend Reports).
- Assist Head of Quality with QMS tasks (dashboards, eQMS training).
Requirements:
- 5-10 years experience with Medical Device QMS (ISO13485:2016) and EU MDR (Regulation (EU) 2017/745).
- Experience writing EU MDR Post Market documentation.
- Experience with eQMS (superuser/administrator preferred).
- Attention to detail and diligence in scheduled tasks.
- Experience with SaMD and medical database products preferred.
- Experience with MDSAP, UKCA, and EMEA regulations preferred.