At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Specialist-II Careers that Change Lives Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow. A Day in the Life Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Prepare, review, file, and support premarket documents for global registrations for assigned projects. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop Regulatory Strategies for new or modified products for assigned projects. Monitor and provide information pertaining to impact of changes in the regulatory environment. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal documents for modifications to devices, when appropriate. Participate in health agency inspections & notified body audits as necessary. Author and/or review regulatory procedures and update as necessary. Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information. Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects. Ensure compliance to regulations specific to clearance and approvals of MEIC developed product s raw material and/or prototype. Minimum Qualifications Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors 4-7 years experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure; Good at English, including reading, writing, and speaking; Good Learning attitude Nice to Haves US and global regulatory affairs knowledge and experience. Experience working with cross-functional teams. Effective verbal and written communication skills both internally and externally. Experience with solving problems and concerns. Experience with project management and adherence to time schedules. Work well under pressure in a dynamic environment. Highly organized, detail-oriented, and efficient. Team player who seeks to help and learn from colleagues seeing the department success as their own Ability to manage projects to completion within and outside of the direct department and company. Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism Proactively seeks to develop and become well-versed within the regulatory landscape. RAPS Regulatory Affairs Certification (RAC). About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let s work together to address universal healthcare needs and improve patients lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
