My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. In this role, you will be responsible for all activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle while building and managing a regulatory team.
Responsibilities:
Develop strategies for regulatory approval of medical devices worldwide based on business needs.
Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.
Prepare global regulatory applications, including US medical submissions (pre-submissions, 510ks, IDEs, and annual reports) and EU MDR, and design dossiers and technical files for other international markets.
Interact with the US FDA and other regulatory authorities worldwide.
Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in the Complaint System.
Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
Participate in Risk Management assessments.
Review design and manufacturing changes for compliance with applicable regulations.
Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents.
Support quality system audits by notified bodies, government agencies, and customers.
Assist with environmental regulations and standards (e.g., RoHS, REACH, etc.).
Hire, mentor, and train regulatory staff; engage outside contractors as needed.
Perform all other essential duties as assigned.
Requirements:
Must have experience with Class II programmable electro-mechanical and sterile medical devices.
Bachelor's degree, preferably in an engineering or life sciences discipline, advanced degree preferred.
10+ years of regulatory experience with US and international submissions.
Demonstrated aptitude for preparing and submitting 510(k)'s and international design dossiers for new products.
Medical Laser experience preferred.
Prior interaction with the FDA and other worldwide agencies is required.
Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, including FDA QSR's, ISO 13485, 14971, 10993, 11607, 14644, 14698, 15223, 11135, 11138, 11737, 17665, and 22442, and IEC 60601, 60825, 62304, and 62366.
Experience in building and managing regulatory teams and leading cross-functional project teams on collaborative projects.
Strong working knowledge of Microsoft Word and Excel.