Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Regulatory Affairs Specialist* This position assists the Director of Quality Operations (DQO) in maintaining an effective Quality Operations and Regulatory Program which consistently delivers high quality EZIP products on time.
- Handles regulatory submissions CAPAs customer complaints conducts regulatory reviews and participates in audits to verify that appropriate current procedures and applicable regulations are followed and keeps the DQO fully informed on status of QA QC DC and RA activities.
- Deliver high quality products on time.
- Handle regulatory submissions CAPAs customer complaints.
- Conduct regulatory reviews and participate in audits to verify that proper procedures and applicable regulations are followed.
- Keep DQO informed on status of QA QC DC and RA activities.
- Knowledge of FDA medical devices and/or pharmaceutical (drug) registrations.
- Familiar with regulatory submissions and performing audits.
- Experienced in QA systems: FDA ISO 13485 MDR/MDD MDSAP.
- Selfstarter strong communicator and has good time and projectmanagement.
- Detail oriented organized and has excellent verbal and written communication skills.
- Proficient in Microsoft Word Excel and ERP/MRP software.
- Must be on site in the office 5 days a week.
- Must be available to work overtime if necessary.
- skills: CMC GCP (Good Clinical Practice).
Employment Type
Full Time
