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