Description
A global medical device company is seeking a Senior Specialist for their growing product lifecycle group. The Senior Regulatory Affairs Specialist provides and often leads regulatory support for new and existing class II and III medical device products.- Prepares timely amendments, supplements, annual reports and other regulatory documents for review and approval by Manager.
- Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and draft reports and narrative components in accordance with regulatory agencies' guidelines.
- Prepare and submit PMA or 510(k)s (FDA) and/or International submissions experience to obtain regulatory clearances for new products and product changes in a timely manner.
- Prepare "Memo to File" reports to support internal filings for product development projects and product changes.
Requirements/Qualifications
- 4+ Years Regulatory Affairs Experience
- BA/BS Degree (Engineering or Scientific Field a plus)
- Expertise in Pre-Market notification 510(k) guidelines and/or International Regulatory Affairs
- RAPs (preferred)
To find out more about Real please visit www.realstaffing.com