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Medical Device: Regulatory Affairs Specialist, Regulatory Affairs Manager

Company Name: Mattson Resources
Location: Irvine, CA
Job Type: Full Time (Direct Hire)
Contact Name: Lucrecia Alcosser
Phone: 714-881-1850
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: RA Specialist: 75K - $110K; RA Manager: $130K+

Job Description

Mattson Resources is working with several Medical Device companies seeking experienced Regulatory Affairs professionals: growing, “post” startups with established products in market and strong leadership with plans for additional growth and new product development.  Currently have 2 openings: RA Specialist and Sr. RA Manager – overseeing small team.  Opportunities located in IRVINE and South Orange county.

Job Requirements

BS/BA Degree; 3+ years of RA experience for RA Specialist role and 7+ years of Regulatory Affairs experience for Manager role

  • Medical Device class II/III

  • Knowledge of US and international medical device regulatory requirements

  • Experience in 510(k), PMA, Technical File, Design Dossier

  • Ability to work effectively in a team environment