Director/Senior Director, Regulatory Affairs

Job Summary:

• Creation, development, and submission of new product regulatory submission documents in the cardiac electrophysiology field
• Maintenance of technically related regulatory documentation for existing products to include but not be limited to risk management documentation, essential requirements checklists, and trace matrices.
• Regulatory contribution to design control activities for existing and new products
• Ensure that domestic and international regulatory filings assigned meet regulatory requirements.
• Prepare and submit regulatory submissions to obtain approval to conduct domestic and international clinical investigations and to seek regulatory approval to commercialize the new products and their accessories (IDE supplements, PMA, Annual reports, change notices, etc.). 
• Monitor Engineering Change activities and prepare required regulatory submissions for implementation of engineering changes.
• Review existing product regulatory documentation and ensure at least an annual update of technically related regulatory documents including but not limited to risk management documentation, essential requirements checklists, trace matrices, etc.
• Identify and resolve regulatory/quality issues throughout the product development process to assure successful regulatory filings.
• Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams.  Expertise in domestic and international regulatory standards etc. required.
• Create project plan, manage timelines and priorities on all submissions and ensure that submissions are processed in a timely fashion.
• Manage technical file documentation for international approvals in multiple geographies.
• Determine strategy, content, and structure of domestic and international regulatory filings
• Determine timelines for regulatory filings
• Back-up approver for regulatory documentation in the company’s document control system
• Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
• Understanding that device defects may occur from the improper performance of specific job functions, including those personnel performing or participating in invalidations.
• Each country has regulatory requirements which must be adhered to, which can impact individual roles within the company.
• Understanding of individual role in achieving company quality objectives and QMS compliance.

Qualifications:

• Ph.D. in Regulatory Affairs or equivalent work experience
• 15+ years experience in Regulatory Affairs position with primary responsibility for preparing regulatory submissions for Class III devices
• Active implantable device experience is highly desired.
• Electrophysiology or related life science – Desired
• Mechanical, electrical, or biomedical engineering degree or background – Desired
• Excellent Knowledge of domestic and international regulations 
• Excellent written and verbal communication skills.
• Excellent interpersonal relationship skills.