Job Summary

A medical technology company has a current position open for a Remote Software Interoperability Staff Regulatory Affairs Specialist in San Jose.

Candidates will be responsible for the following:

• Preparing complex submissions to gain global approvals for clinical research
• Applying software and security (i.e., cybersecurity) regulatory standards
• Demonstrating knowledge and skills in areas of regulatory pathways

Qualifications Include:

• Travel Percentage: 20%
• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required
• A minimum of 5 years of experience in a relevant regulated industry
• A minimum of 3 years of Regulatory Affairs experience
• Excellent analytical and writing skills
• Excellent interpersonal, written and oral communication skills