Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics

Responsibilities: We currently have a great opportunity for a Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics. The Senior Manager position in Regulatory Affairs and Quality Assurance leads the regulatory strategy for new and modified Surgical Robotics products. The individual will lead, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. The individual is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications. The individual may have the opportunity to manage team members and will report to the Sr. Director, Regulatory Affairs.

Essential Duties and Responsibilities: 1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes2. Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA, Health Canada and other country-specific regulations as required.3. Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards and set team objectives to ensure alignment with business and regulatory strategies.4. Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.5. Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced. Also ensuring adherence to internal procedures. Evaluate and implement continuous improvement in internal processes and procedures.6. Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for medical devices products. 7. Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.8. Support internal and external audits, including ISO and/or regulatory body audits.9. Support the maintenance and continuous improvement of the quality management system to ensure ongoing compliance with applicable ISO standards and regulatory requirements.10. Conduct post-market surveillance activities and support post-approval products through change evaluation and submission and annual reporting as required. Other duties as assigned.