In this exciting role as a Regulatory Affairs Manager, you will have responsibility for leading a team or Regulatory Specialist in developing and executing on global regulatory approvals to introduce new and modified medical devices to the market for Medtronic's' Aortic and Peripheral Vascular (APV) business.
A Day in the Life
As the Regulatory Affairs Manager, you will provide management support to submissions, regulatory activities, clerical staff, and supervise the preparation of deliverables to introduce new/ changed products to global markets. You will often lead the regulatory support for new and existing products and implements worldwide regulatory plans.
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 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.
Must Have: Minimum Requirements
5-7 years of regulatory or engineering experience with Bachelors
3-5 years of regulatory or engineering experience with Masters or other Advanced Degree
3+ years of experience providing work direction and/or leadership to people and teams
Nice to Have
Experience at formulating and implementing successful regulatory strategies • Leadership capability (demonstrated) • Highly motivated and results-oriented leader • Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems • Proficiency in FDA compliance • Excellent written and verbal communication, technical writing, and editing skills. • Demonstrated advanced software skills including Microsoft Word, excel, database (i.e. RAD/Documentum) and Adobe software skills. • Excellent Project-management skills and experience. • Detail-oriented • Ability to be flexible with changing priorities. • Submission-related word processing skills
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 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. The physical demands described within the Day in the Life 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.
Internal Number: 18000JO2
Making healthcare better is our priority, and we believe medical technology can play an even greater role in improving people’s lives. With challenges facing families and healthcare systems — such as rising costs, aging populations, and the burden of chronic disease — we are harnessing the power of technology to take healthcare Further, Together. Innovation and collaboration are central to who we are. Since the late 1940s, we have been working with others to alleviate pain, restore health, and extend life. Today, we are a medical technology leader offering therapies and solutions that enable greater efficiency, access, and value — for healthcare systems, providers, and the people they serve.