Senior Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. 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. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections. Responsibilities may include the following and other duties may be assigned: Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information. Prepare, review, file, and support premarket documents for global registrations for assigned projects. Provide requested regulatory data and documents to support tenders. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. May direct interaction with regulatory agencies on defined matters. Develop Regulatory Strategies for new or modified products for assigned projects. Monitor and provide information pertaining to impact of changes in the regulatory environment. Communicate with regulatory agencies and/or notify bodies on administrative and routine matters. Document, consolidate, and maintain oral and written communication with health authorities. Prepare internal documents for modifications to devices, when appropriate. Author and/or review regulatory procedures and update as necessary. Coach peers on matters related to international submissions and other related regulatory programs. Identify opportunities for process improvements and organization for business impact and efficiency. Required knowledge and experience: Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors. 7+ year’s experience for RA role in medical device and or pharmaceutical industry. Works independently with general supervision on larger, moderately complex projects / assignments. Contributes to the completion of project milestones. Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communicates primarily and frequently with internal contacts.