Description
- Preparation of clinical trial protocols, qualifying clinical sites, management of CROs, budgets and associated filings. Preparation of study reports to support filing activities.
- Review change control process as it pertains to reportable changes to FDA
- Preparation of 30-day notice and / or 135-day supplements for PMA products
- Preparation of PMA applications
- Preparation of 510(k) filings (FDA), Prequalification filings (WHO), technical files (CE)
- Responsible for maintaining technical files and CE marking process
- Responsible for annual products/facility license review as per USDA CVB regulations
- Prepare amendments to facility, outline of production and labeling as needed to CVB
- Prepare annual reports to FDA
- Performregulatory review of complaints as per MDR and USDA requirements
- Manage and maintain regulatory filing schedules
Requirements:
- 3-5 years experience in Regulatory Affairs and preferrably Diagnostics
- Creative personality, strong leadership skills
To find out more about Real please visit www.realstaffing.com