What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- 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.
- Self-starter, strong communicator, and has good time and project-management.
- 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).
