Manager / Sr. Mgr, Regulatory Affairs - Class III Med Dev - Lake Forest, CA

Lake Forest, CA | Direct Hire

Post Date: 08/21/17 Job ID: 68747-TM Industry or Function: Biotech-Science Compensation: $ 120,000 to $ 150,000

JOB #: 68747-TM

JOB DESCRIPTION: TriStaff is partnering with a late stage startup class III medical device company to find a Senior Regulatory Affairs Specialist for its growing team. The company obtained FDA approval last year so it’s a very exciting time for them! You MUST have experience working with a class III medical device and some post-market experience. You must also be comfortable working in a small, fast paced environment and with cross-functional teams.

Job Duties:
• Prepare US and International regulatory submissions
• Work with management to devise strategies to ensure rapid and timely approval of devices
• Plan and implement regulatory activities
• Work closely with cross-functional teams

Salary Range and Bonus Potential:
• $ 120,000 to $ 150,000
• Annual bonus

• Medical, dental, vision insurance
• Stock options
• PTO and holiday pay
• Extensive opportunity for growth

Job Requirements:
• Must have experience with a class III medical device
• Must have post-market experience
• Must have a Bachelor’s degree
• 6-10 years’ experience in Regulatory Affairs

Educational Requirements:
• Bachelor’s degree required

KEY WORDS: regulatory affairs, post-market, pre-market, class III, PMA, medical device, FDA



Megan Marsh

I am an East Coast native and earned a BA degree in Psychology from the University of Virginia. After recruiting for a year in Washington, D.C., I moved out to San Diego, CA and joined TriStaff in 2007 as a Technical Recruiter. Since 2013, I’ve been an Engineering & Executive Search Recruiter, specializing in hardware engineering recruitment within Southern California. The majority of my clients are small, well-funded startups within the medical device and consumer electronics industries. Positions that I specialize in: Mechanical Engineers, Electrical Engineers, Quality Assurance, Manufacturing Engineers, Systems Engineers, Operations, Project Managers. I’m also the proud mother of two strong-willed daughters, and my husband is the Director of Operations at a local startup Medical Device Company, so I’m deeply embedded in the engineering space!
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