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: Set up new process for entering new data - Regulatory Information Management System. Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes. Keeps abreast of regulatory procedures and changes. Provide requested regulatory data and documents to support tenders Keeps abreast of regulatory procedures and changes. 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. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections. 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. Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. 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. Ability to quickly establish credibility with all levels of customer base. Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.

Skills: Excellent communication and interpersonal skills. Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. Self-motivated and positive. Ability to quickly establish credibility with all levels of customer base.   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