Careers That Change Lives The Diabetes Group at Medtronic is part of Medtronic PLC, the global leader in medical technology. We are committed to ongoing breakthrough developments in leading-edge technology, unrivaled service and support, and uncompromising leadership. Medtronic is 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. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. A Day in the Life Responsibilities may include the following and other duties may be assigned. This position willprovide support and guidance to Program Management Leaders and cross functional team members on navigating through product development activities through the product lifecycle ensuring compliance with regulations and standards. This role is critical to ensuring that products meet regulatory requirements and quality standards throughout the design process. In this role you will help mitigate risks, ensure compliance with relevant regulations, and maintain product integrity. Proactive individual with expert level understanding of design controls and ability to apply knowledge to influence product development Standard Operating Procedures and provide guidance to Product Innovation leaders. Experienced auditing design history files to ensure compliance with regulations and standards. Monitor changes in regulations and update internal procedures as needed. Must be a strong team player with excellent communication skills that will drive optimization of design control processes in collaboration with Quality, Regulatory & other key stakeholders’ groups. Experience with cross functional project teamwork and collaboration with R&D, QA, RA, Marketing, Usability and Manufacturing team members. Strong team building and knowledge sharing skills to establish best practices, train and develop team members. Implement industry best practices and provide training, establish compliance metrics, and address or escalate issues for resolution. Must Have: Minimum Requirements Bachelor’s degree and 7 years of relevant experience, or advanced degree and 5 years of relevant experience Nice to Have: MBA preferred PMP Certification and/or certifications related to Quality Technical degree is a plus. Experience with Design Control documentation within medical device industry or Pharma industry. Experience conducting and organizing training, mentoring, and guidance for cross functional teams through design control and regulation requirements. Excellent written and verbal communication skills; ability to present information to cross functional audiences and management. Subject matter expert in all phases of product development lifecycle (design input/output and V&V). High degree of initiative and self-motivation. Prior work experience in a regulated industry (Medical Device Industry preferred) Sound experience and through knowledge of FDA 21/CFR Part 820 and ISO 13485 Experience with Risk Management in medical devices is an advantage.