Sr Director Global Regulatory Intelligence – Medical Devices

Sr Director Global Regulatory Intelligence – Medical Devices

Requirements

• Expert knowledge of applicable rules, regulations, and guidance related to premarket submissions, including clinical studies
• Expert knowledge of QSR
• Knowledge of technical standards and their use, e.g., IEC, ISO
• Ability to effectively interact directly with regulators to achieve company goals
• Ability to build consensus and to negotiate a favorable position for the company
• Expertise interacting with regulatory agencies including leading meetings with regulatory agencies
• Proven track record of effective collaboration with regulatory agencies, e.g., successful clearances and meeting deadlines for submissions in a least burdensome manner
• Expert knowledge of applicable regulatory requirements
• Capability of building strong relationships with internal and global partners, considering language and cultural differences
• High capacity and ability to manage multiple teams, various complex tasks and projects, and highly visible and impactful assignments
• Strong verbal and written communication skills in English, with multiple levels of leadership
• Exceptional interpersonal skills and excellent ability to work well with cross-functional teams
• Experience and application of process implementations and improvements, e.g. writing and implementing SOPs
• Ability to translate regulatory requirements into task driven processes and procedures
• Experience with external auditors or inspectors
• Ability to quickly read, understand, write, and communicate complex technical and medical information, e.g. engineering drawings, test reports, peer-reviewed publications in clinical and engineering journals
• Bachelor’s degree in science, engineering, technology, or mathematics (advanced degree preferred)
• Minimum of 10+ years’ experience leading cross functional teams

Responsibilities

• Develop and expand Global Regulatory Intelligence footprint
• Prepare the organization to gather intelligence on current and future regulations
• Lead cross-functional reviews and assessments for new regulations or certifications
• Develop and drive internal regulatory clinical evidence strategies for CE marking and other regions
• Support and oversee processes related to compliance with the EU Medical Device Regulation (EU MDR)
• Manage clinical evaluation planning, PMCF processes, CEP, and new processes for real-world evidence to support regulatory submissions
• Serve as the corporate point of contact for the EU Notified Body
• Oversee product indications and consolidation, as well as the management of on- and off-label uses by region
• Drive regulatory advertising and promotion (A&P) activities
• Manage the full scope of the A&P process globally and its supporting personnel
• Chair the A&P committee with the clinical and marketing team functions
• Act as a primary source of expertise related to A&P materials within the organization
• Create and improve the maturity and compliance of Standard Operating Procedures (SOPs), templates, forms, and logs
• Liaise between in-country clinical, marketing teams in the Direct and Indirect QARA groups, Subject Matter Experts and Regulatory Affairs
• Work closely with other managers and leadership teams to improve regulatory requirements monitoring
• Develop relationships necessary to exchange data and information with other intelligence groups across Intuitive
• Ensure that periodic updates are prepared as required by leadership and management forums
• Compile and report process metrics and KPIs related to Veeva tool
• Work closely with the global regulatory, clinical and compliance organizations to ensure compliance
• Drive intelligence and communication of emerging regulatory trends and implications to internal stakeholders
• Provide insights and direction to key internal stakeholders
• Ensure business requirements are defined/captured in relationship to standards application and management

Preferred Qualifications

• RAC certification is a plus
• Experience working with professional or trade associations regionally and by country (eg Advamed, BvMed, Snitem, …)