Summary of Position with General Responsibilities:

Manages the Regulatory Affairs department while also participating on project teams as the Regulatory Affairs core team member.
Responsible for the supervision of a regulatory submissions group, the development of a regulatory strategy on new medical devices, and high-level supervision of the preparation and submission of the Food and Drug Administration (FDA) submission packages in an accurate and timely manner including, but not limited to: 510(k)’s, IDE’s, and PMA’s.
Also responsible for managing, developing, coaching and mentoring direct reports.

Essential Job Functions:

- Develop regulatory policies, goals, and executive reports.

- Determine effective regulatory procedures and project plans from each project to ensure that FDA regulations and our company goals are met.

- Lead multi-departmental and cross-divisional (if applicable) teams to implement the regulatory strategies with respect to the collection, documentation, analysis, and reporting of information for inclusion in FDA submissions.

- Communicate internal Regulatory Affairs procedures and policies.

- Review and approve product labeling, promotional claims, and advertisements to ensure compliance with U.S. and international laws and regulations.

- Provide guidance to Regulatory Affairs staff on issues between our company  and the FDA regarding submission questions and requests for additional information as they arise.

- Manage the Regulatory Affairs department.

Basic Qualifications:

Must possess knowledge of physical science, manufacturing, biology, and regulatory
affairs. Must have experience in managing regulatory affairs in the medical device industry and a thorough knowledge of Food and Drug Administration regulations and procedures. Excellent written and verbal communication skills. Ability to review and evaluate scientific and technical data.

Additional Desirable Qualifications Skills and Knowledge:

- Ensure that action plans are completed for each project.

- Issue periodic status reports on Regulatory Affair's submissions.

- Establish budget and personnel requirements for the department.         

Education and/or Experience:

Bachelor's degree in a scientific discipline or related area.

Minimum of 10 years of experience in Regulatory Affairs with specific experience in Class II 510(k) and Class III ID/PMA submissions.

Minimum of 7 years of managerial experience in medical device industry.