ASSOCIATE REGULATORY AFFAIRS SPECIALIST – Cardiac Rhythm Management (remote) in Mounds View, MN
ASSOCIATE REGULATORY AFFAIRS SPECIALIST - Cardiac Rhythm Management (remote) - Medtronic - Mounds View, MN - work from home job Company Medtronic Job description ASSOCIATE REGULATORY AFFAIRS SPECIALIST - Cardiac Rhythm Management (remote) Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is composed of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Candidates located near a Medtronic facility are preferred. Careers That Change Lives The Associate Regulatory Affairs Specialist will provide regulatory affairs support for CRM products. The Associate Regulatory Affairs Specialist is also responsible for sustaining activities which includes maintaining regulatory approvals and providing assessment of device changes for regulatory implications. A Day In The Life • Develop proficiency in domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies. • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. • Leads or compiles all materials required in new product submissions, license renewals and change submissions. • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. • Monitors and improves tracking / control systems. • Keeps abreast of regulatory procedures and changes. • May direct interaction with regulatory agencies on defined matters. • Recommends strategies for earliest possible approvals of clinical trials applications. • Provide regulatory input for design and manufacturing, including review of specifications, protocols and reports, engineering change notices, technical files, nonconforming materials, product complaints, and product failure analysis. • Prepare and track submissions for FDA and global regulatory agencies, including registration documents, progress reports, supplements, and amendments. • Act as liaison with Medtronic China regulatory personnel to address questions and issues that arise as part of the registration and/or testing process. • Obtain and maintain CFGs including the notarization and legalization, EC/ISO certificates and various other regulatory documents. • Participate in compliance activities that relate to the department and the company as a whole. • Perform other regulatory affairs duties when requested. Must Have Minimum Requirements • Bachelor's degree required with 0 years of regulatory affairs or related experience Nice to Have • Bachelors Degree in health profession, science and/or engineering field • RAC Certification or an advanced degree in regulatory affairs • Two or more years of experience in the medical device industry • Experience with cardiovascular devices and knowledge of QSR and ISO-13485 system requirements • Demonstrated experience in preparing 510(k) submissions for FDA or experience with Class III devices • Demonstrated experience with submissions to the European Union • Demonstrated technical writing skills. • Excellent PC skills, including word processing, spreadsheets. • Excellent organizational and judgment skills. • Ability to maintain and generate accurate records. • Strong written, verbal and interpersonal skills • Experience in the use of ERP systems such as SAP • Candidates located near a Medtronic facility are preferred 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. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles While performing the duties of this job, the employee is