SENIOR REGULATORY AFFAIRS SPECIALIST - Digital TechnologiesTheSenior Regulatory Affairs Specialistwill play a key role in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the Senior Specialist works directly with the NPD team from the concept phase through commercialization. The Senior Specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting "no file" decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world's leading medical device company.Location:The preference is for this position to be based in Boston, MA but a remote assignment may be considered within the U.S. Business UnitIn the Surgical Digital Technologies (DT) business, part of Medtronic's Medical Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to expand global access to care and reduce variability through robotic and laparoscopic AI/ML analytics-based solutions.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.Careers That Change LivesTogether, 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.A Day In The LifeDirects 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 submissions, license renewal and annual registrations.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.Additional tasks as assignedMust Have: Minimum RequirementsBachelor's degree with 4+ years of experience in regulatory affairsORAn advanced degree with 2+ years of experience in regulatory affairsNice to HaveExperience in Pre-Sub, IDE, 510(k), De Novo, or PMA; Technical File/Design Dossier, and software-containing devices.Good understanding of product development process and design control through knowledge of US FDA and international medical device regulationsPrior direct involvement with software and/or AI product development teamsWorking knowledge of IEC 62304 standardWorking knowledge of IEC 60601-series standardPrior experience with software-driven devicesFamiliarity with regulatory requirements in major international marketsRegulatory Affairs Certification (RAC) or advanced degree in regulatory affairsExperience in assembling facts from various areas, analyzing data, and providing informed recommendationsMust be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.Ability to compile data and summarize resultsProficiency in FDA compliance.Organized, efficient, process-oriented; high attention to detailEffective interpersonal/communication skillsWorks well under pressure in a dynamic timeline-driven environmentAbility to effectively manage multiple projects and prioritiesDemonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skillsAbout MedtronicTogether, 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 RequirementsThe 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 regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)CompensationA 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. Learn more about our benefitshere. This position is eligible for a short-term incentive plan.Learn more about Medtronic Incentive Plan (MIP) on page 6here. The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc.
