Regulatory Affairs Specialist

Medtronic Career Opportunity

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Drive product registrations, maintain licenses, ensure post-market compliance, and act as a crucial bridge between local commercial teams and regional regulatory bodies to guarantee patient access to life-saving medical devices

This role is responsible for driving product registrations, maintaining licenses, and ensuring ongoing post-market regulatory compliance. The position serves as a critical bridge between local commercial teams and regional regulatory bodies to ensure timely patient access to life-saving medical devices.

Responsibilities may include the following and other duties may be assigned.

• 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.

Required Knowledge and Experience:

• Bachelor's degree required (or equivalent qualification in line with regulatory standards); advanced degree preferred
• Minimum 4 years of relevant experience in regulatory affairs within the medical device or healthcare industry
• Working knowledge of regulatory requirements and submission processes
• Experience supporting product registrations, renewals, and compliance activities
• Strong organizational and documentation skills
• Ability to manage multiple projects and timelines effectively
• Excellent English communication skills, with the ability to collaborate across teams

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.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here