Regulatory Affairs Specialist

Job Description

Duties and Responsibilities:

• Direct or performs coordination and preparation of document packages for regulatory submissions related to the client separation from all areas of company, internal audits and inspections.
• Lead and compile all materials required in submissions related to the client separation Monitor and improve tracking as well as control systems.
• Update regulatory approval data in various systems to ensure data is kept up to date Keep abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Education and Experience:

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related technical field 2-5 years of medical device regulatory experience.