Regulatory Affairs Specialist Jobs

Regulatory Affairs Specialist - GI

This role focuses on regulatory support for global and domestic markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your Regulatory Affairs (RA) skill set every day. In this role, you will have primary RA responsibility for multiple Class II and/or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. From developing 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.

This job opening has a strong preference for candidates to be located in MN or CO as the team is working with flexible working arrangements – around 1 day/ month in the office. May consider remote within the U.S. for the right candidate.

Operating Unit

The Gastrointestinal Operating Unit has created a business out of disrupting the status quo in the detection, prevention, and treatment of gastrointestinal cancers and chronic diseases. We’ve done this by commercializing transformational technologies that improve patient management and standards of care, while increasing access to our innovations across the globe.

Careers That Change Lives

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

A Day in the Life

• Other duties as assigned.
• Monitors and improves tracking / control systems.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Must Have: Minimum Requirements

• Bachelor’s Degree with 2 years of regulatory affairs experience

OR

• An advanced degree with 0 years of regulatory affairs experience

Nice to Have

• Proven ability to work effectively in cross-functional teams
• 510k experience
• EU MDR experience
• Excellent analytical thinking skills
• Submission-related word processing skills
• Demonstrated ability to influence based on experience, facts and data
• Detail-oriented
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Ability to work in matrix teams
• Excellent written and verbal communications skills
• 2+ years of medical device regulatory affairs experience
• Ability to be flexible with changing priorities
• Ability to effectively manage multiple projects and priorities
• Strong organization and time management 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 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Compensation