Regulatory Affairs Manager - Bay Area, CA - Class II Start-Up

Currently seeking a Senior Regulatory Affairs Specialist to join the organization's team at a very exciting time. Seeking an experienced candidate who has a passion for our mission and an unwavering commitment to operational excellence.

Reporting to the Senior VP, Regulatory Affairs, this hands-on role has responsibility for drafting the 510(k) Submission for the device and supporting that Submission through concurrence at FDA. In addition, this role will support both IDE and 510(k) Submission work for next generation devices as well as support select approvals in OUS markets.

The successful candidate will:

* Draft key regulatory submissions and ensure the successful clearance and/or approval of same.
* Work with a talented multi-disciplined engineering group to document, validate, and verify product designs and design changes and confirm compliance with Design Control regulations.
* Review test protocols and test reports to confirm updated designs, and corresponding testing, conform to relevant requirements.

The desired candidate will have:

* 5-7+ years of successful experience with increasingly complex regulatory submissions.
* Direct experience with drafting 510(k) Submissions that were successfully navigated through the approval process at FDA.
* Direct experience drafting original IDE Submissions and relevant Supplements, Annual reports, and other Amendments.
* Experience with CE Mark process including authoring Clinical Experience Summaries, as required by MDD.
* A balanced approach to regulatory judgments.
* Clear and independent thinking.
* A personality that is focused, driven, ambitious and seeks out innovative approaches to challenges.
* A person who thrives in a fast paced, intense culture. A person with high integrity and character, who is tough minded, fair and principled.
* Exceptional communication skills and whose daily actions are culture building.
* The ability to interface effectively with all levels and functions within the organization.
* Strongly preferred, but not mandatory, experience with capital equipment devices that include hardware, firmware and software.

The preferred candidate will have an undergraduate degree in a field relevant to a regulatory position in the medical device industry.
To find out more about Real please visit www.realstaffing.com