Job Summary

A medical device manufacturer has an open position for a Remote Senior Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

• Determine global regulatory pathways for various projects including product classification & type of regulatory submission
• Participate in various teams to define regulatory requirements of U.S. & international submissions, Technical Files, or regulatory rationales
• Identify guidance documents, international standards, Consensus Standards and assist teams with their interpretation

Required Skills:

• Education or experience equivalent to Bachelor's Degree in technical field such as biological, physical, engineering or material science
• AND six years of related industry experience
• Demonstrated knowledge of U.S. FDA regulations, Medical Devices Directive (93/42/EEC, as amended) & various Quality System Laws
• Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers
• Demonstrated computer skills preferably spreadsheets, word processing, database, internet research & other software programs