Regulatory Operation Specialist (Remote)

About the position

The Regulatory Operations Specialist at Medtronic will serve as the primary contact for product release and regulatory submissions for both US and international markets. This role is crucial in ensuring compliance with regulations and internal procedures, while also participating in various regulatory operations activities. The position offers opportunities for process improvement and collaboration across teams to enhance healthcare access and equity.

Responsibilities

• Understand and operate within regulatory guidelines on electronic submissions, general regulatory requirements, and internal procedures
• Review and approve requests for product release and resolve blocked orders, ensuring timely and accurate delivery of products to patients
• Keep systems of record updated with current and accurate information pertaining to regulatory work
• Partner with team members and customers to share knowledge and solve problems
• Provide formatting and publication expertise to agency submissions
• Identify opportunities for process improvement and participate in projects as a subject matter expert
• Maintain and update assigned standard operating procedures, policies, work instructions, and user guides, as needed
• Lead training on Regulatory Affairs systems and procedures, troubleshooting and providing problem resolution for complicated issues
• Lead data collection and management for UDI submissions in US and international markets
• Lead and support special projects under direction from manager including, but not limited to, collecting and analyzing data, and presenting results
• Foster relationships across functional groups and business units to share best practices

Requirements

• Bachelor's Degree with 2 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality systems
• Or advanced degree with 0 years of experience

Nice-to-haves

• Knowledge of GTS licensing, UDI coordination and EU MDR preferred
• Advanced customer service skills to interact with individuals at various levels of the organization and external contacts, when necessary
• Strong organizational and time management skills, including meticulous attention to detail and the ability to complete multiple simultaneous assignments with minimal supervision
• Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry
• Advanced knowledge and use of Microsoft Office Suite applications, Outlook, Word, Excel and Adobe Acrobat
• Analytical and problem-solving skills associated with software and complex documents
• Ability to quickly learn new computer technology software packages with minimal training
• Expertise on general records management and archiving strategies
• Advanced written and verbal communication skills
• Ability to work with established procedures and to establish processes and procedures as needed

Benefits

• Competitive Salary
• Flexible Benefits Package
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Plan
• Paid Time Off