The Regulatory Affairs Operations Manager manages domestic and international regulatory operation activities for Medtronic Diabetes within the Regulatory Affairs department. Individual will work closely with the Regulatory Affairs team to help manage, coordinate and streamline procedures and strategies as appropriate.
The Regulatory Affairs Operations Manager will oversee execution of various projects across business units to achieve objectives related to regulatory compliance in the US and Internationally. Additionally, this role will assist in the implementation of new technologies to improve the Regulatory Affairs Department's product master data management capabilities. This position requires the individual to take complex ideas and translate them into easy to understand information to all levels of the organization, improve processes and systems to enhance performance of the job area and assist in change management to implement ideas.
A Day in the Life / Responsibilities:
The Regulatory Operations Manager will manage, coordinate, develop and implement regulatory operation strategies related to US and International submissions and be responsible for leading process and/or system change management. In addition, you will be responsible for communicating regulatory operations status to team members and senior management. The Regulatory Operations Manager will also provide direction and mentoring to department personnel including establishing priorities, monitoring performance and identifying qualified candidates to fill open positions.
• Developing, improving, and maintaining IT-system enhancements related to Regulatory Affairs and Regulatory Operations activities including processes related to product release, document management and publishing systems in use by Regulatory Affairs.
• Interfacing with project managers, regulatory product managers, publishers and/or content authors to discuss routine and non-routine submission preparation, ensuring acknowledgments and approvals from notified bodies are received, processed and stored in compliant systems.
• Representing Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Maintaining working knowledge of the regulations and processes that govern the maintenance of controlled documents required by notified bodies.
• Ensuring procedures for product release and product licensing in US and Internationally are accurate, efficient, and follow best practices.
• Maintaining, updating, and improving department procedures and policies.
Medtronic Diabetes Group
The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems. We are working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
• Bachelor's Degree
• 5+ years of work experience in US Regulatory Operations in Medical Device or Pharmaceutical Industries with Bachelor's degree.
• 3+ years of work experience in US Regulatory Operations in Medical Device or Pharmaceutical Industries with Master's degree.
• Strong organizational and project management skills. This includes meticulous attention to detail and the ability to complete multiple simultaneous assignments within a given period of time and with minimal supervision. Experience managing small projects and demonstrated effectiveness working in multidisciplinary teams. Strong analytical skills, able to prioritize, plan, and organize across work streams
• Excellent written and verbal communication, especially presentation and facilitation skills
• Ability to work in a demanding, time-sensitive environment and to adapt quickly to changing requirements and priorities.
• Strong leadership, interpersonal, and influencing skills and with demonstrated ability to mentor, and develop others
• Proven business acumen with general management perspective
• Interest in and passion for the medical device industry and bringing innovation to market
• Advanced level knowledge and use of Adobe Acrobat or other Adobe plug-in publishing tools, advanced to expert level knowledge and experience with Microsoft applications, including creating templates (styles), editing and formatting complex documents in Word, PowerPoint, Visio, Excel, SharePoint, InfoPath, Teams, etc.
• Knowledge of regulatory authority procedures/guidance's regarding electronic submissions.
• Knowledge of electronic document management systems and publishing systems.
• Knowledge of Global Trade Services (GTS), unique device identifier (UDI), and other regulatory databases within the US and Internationally
• Knowledge of and an interest in master data management principles and applications
• Knowledge of the European Medical Device Regulation (EU MDR)
• Demonstrated deep understanding of project, risk, and communications management
• Regulatory Affairs Certification (RAC)
• Project Management Professional Certification (PMP)
• Lean Six Sigma Certification (Green Belt)
• Information Technology Infrastructure Library Foundations Certification (ITIL)
• Experience deploying a Product Information Management (PIM) system or Master Data Management (MDM) system
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)