Director, Regulatory Affairs.

Job Summary

This position is responsible for managing resource allocations for product development, sustaining production, and quality improvement projects.  Maintains current knowledge of global medical device regulations, acts as consultant to other departments, participates in decision-making concerning policies, regulatory requirements and strategies, and manages external consultants as needed.  Defines information and actions needed to meet requirements, prepares documents and/or submissions required to obtain clearance or approval from governmental agencies for global commercial distribution of products.  Guides and supports acquisition and partnership development projects with attention to due diligence and subsequent regulatory compliance.  Maintains compliance standing with regulatory and certifying agencies.

Job Details/Responsibilities

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
2. Provide expertise to global regulatory strategy development and implementation to achieve completed regulatory submissions in a timely and fiscally responsible manner.
3. Establish and execute submission schedule(s) and achieve plan commitments.  Assure tactical objectives are achieved in U.S. and non-U.S. submissions, label and advertising review, removals and corrections support as well as recommend and implement procedural improvements.
4. Assure compliance requirements are achieved.  Interface with U.S. and non-U.S. government officials on compliance issues that assures credibility bringing issues to successful resolution.
5. Manage timely regulatory clearances for new products; maintain existing marketing authorizations.
6. Prepare U.S. and non-U.S. submissions including but not limited to IDE, 510(k), technical files, establishment registration and device listing.
7. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
8. Perform other duties as assigned.

Qualifications/ Background Experiences

Requires a four-year college degree and a minimum of ten years of experience in Regulatory Affairs and/or Quality for medical devices or pharmaceuticals, including one or more of the following: clinical studies, global marketing applications, or quality systems management. Of the ten years of experience a minimum of seven years must include supervisory experience.  Basic computer software skills, i.e., Microsoft Office. Advanced degree or additional professional training preferred.