Senior Manager, Regulatory Affairs

Job Summary:

The Senior Manager will work on the creation, development, and submission of new product regulatory submission documents in the cardiac electrophysiology field.  The successful candidate will maintain technical regulatory documentation, risk management documentation, essential requirements checklists, and trace matrices while contributing to design control activities for new and existing products. 

Job Responsibilities:

• 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 (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 a 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 plans, 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.

Qualifications/Experience:

• · 5+ years’ experience in Regulatory Affairs position with responsibility for preparing regulatory submissions for Class III devices – Required
• · Excellent knowledge of domestic and international regulations – Required
• · Active implantable device experience – Highly Desired.
• · Mechanical, electrical, or biomedical engineering degree or background – Highly Desired
• · Electrophysiology or related life science background – Desired
• · MS or Ph.D. in a technical field – Desired
• · Excellent written and verbal communication skills.
• · Excellent interpersonal relationship skills.