Regulatory Affairs Specialist
Essential Duties and Responsibilities: include the following; other duties may be
Avalign Technologies; currently Avalign Surgical business and Corporate R&D function.
policies and procedures.
for compliance with applicable regulations and policies.
pathways, compliance test requirements, or clarification and follow-up of submissions under review.
requirements, or other compliance issues.
situations such as proposed device changes, labeling changes, or new items added to the company offering.
Education and/or Experience:
Qualified candidates will have a Bachelor's degree in a scientific discipline, at least 2+ years of related Regulatory Affairs Specialist (or similar) experience in the medical industry, experience with regulatory submissions (US and International), and a working knowledge of FDA, ISO regulations, and the EU Medical Device Regulation. Avalign is an EOE Employer.