Staff Regulatory Affairs Specialist - Pleasanton, CA

Calyxo, Inc. is a medical device company seeking a high-achieving Staff Regulatory Affairs Specialist to drive complex U.S. and international submissions, shape regulatory strategy, and mentor junior team members.

Requirements

• 12+ years' experience in regulatory affairs in medical device, biotechnology, or in-vitro diagnostics (IVD) industry
• Extensive prior experience interfacing with the FDA and/or other regulatory agencies
• Proven success independently leading multiple FDA submissions, including 510(k)s, Special 510(k)s, Q-Subs, and/or PMAs

Benefits

• Competitive salary of $160,000 - $175,000
• Variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• 401(k)
• Healthcare insurance
• Paid vacation