Roles & Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
• Leads or compiles all materials required in submissions, license renewal, and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and the clinical protocol for regulatory compliance.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for the earliest possible approvals of clinical trial applications.

Job Skills:

• Knowledge of FDA, EU, MHLW, and TGA requirements
• US FDA PMA, 510(k) and European Union submission experience (desired)
• Strong communication skills
• Strong technical writing skills

Education and Experience:

• Bachelor's degree in related field; Regulatory Affairs Certification (desired)
• 5 years of the significant US and International medical device submission experience and/or regulatory affairs experience.