As Director of Regulatory Affairs, you will direct teams of regulatory professionals including operations and international associates, and own responsibility for the process of international regulatory license submission and maintenance, and releasing products for distribution through GTS. This individual will be responsible for the hiring and development of teams to drive international regulatory submission strategy and to support the distribution and control of product worldwide through GTS.
Leadership responsibilities:
• Provide leadership to Regulatory Affairs personnel as they serve as regulatory representative and team members on project teams
• Oversee the development and implementation of company and departmental SOP’s
• Ensure NV compliance with applicable FDA, ISO, and individual country laws and regulations
• Work effectively with peers, senior leaders, and other functions such as Clinical Research, Sales and Marketing, and Research and Development personnel to ensure that regulatory requirements are communicated and understood
• Define ownership, roles, and responsibilities for direct reports and teams
• Prioritize resources for initiatives directly managed by NV regulatory affairs with appropriate inputs related to compliance needs, timing and budget
• Develop and maintain training/compliance programs for department personnel
• Prepare and manage department budget
• Establish and publish metrics for assessing submission quality, timelines, and compliance
• Comply and assure department compliance with Medtronic Policies and Procedures
• Other duties as assigned or required
International Responsibilities:
• Provide Leadership to NV OUS Regulatory Affairs strategies, programs and/or personnel
• Provide Leadership to OUS regulatory and clinical program strategy development, and implementation
• Lead the Regulatory Affairs department in the timely creation and submission of OUS regulatory applications
• Assure department personnel remain current with news of changes in international laws and regulations
Operational Responsibilities:
• Responsible for all aspects of SAP/GTS regulatory operations process including resourcing, metrics and training
• Ensure representation of NV business interests and awareness of all SAP/GTS development and change activities from corporate teams
• Ensure resource Coverage of GTS for all Neurovascular Products globally
• Responsible for the UDI process globally including resourcing, execution, training and tracking
• Ensure representation of NV business interests and awareness of all global regulatory affairs domain system activities
• Responsible for the success of software implementations within NV regulatory affairs
• Responsible for the decision making process for NV IT Regulatory system enhancements
Qualifications
Basic Qualifications:
• Bachelor’s Degree in scientific or health related field
• Demonstrated ability to lead people and projects
• 10+ years of experience of US and/or OUS medical device Regulatory, Medical, or Clinical Affairs with university degree or 8+ years of experience of US and/or OUS medical device Regulatory, Medical, or Clinical Affairs with advanced degree
• 7+years of managerial experience
• Working knowledge of US and OUS clinical research regulations and techniques
• Demonstrated ability to effectively implement and manage complex global product development projects and regulatory strategy
• Demonstrated knowledge of all aspects of regulatory affairs project execution
• Excellent written and verbal communication skills required
Preferred Qualifications:
• Minimum 10 years’ experience of US and/or OUS medical device or pharmaceutical Regulatory Affairs
• Strong knowledge of IDE, PMA, 510(k), MDD, MHLW, ISO, and QSR requirements and execution
• 5 years of US and OUS submission preparation experience
• Experience with MDR, Vigilance, and other regulatory compliance programs
• Regulatory Affairs Certification
• Knowledge of FDA, EU, MHLW, and TGA requirements
Now submit your application online and subscribe to email or follow us on twitter to get similar jobs in the future.
Posts
