We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.
Together, we can confront the challenges that will change the face of healthcare.
Careers that Change Lives
The Principal Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II & III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs associates and provides work direction on projects of large scale with significant business impact.
A Day in the Life
Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
Review only significant submission decisions/content issues with manager.
Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
Provide feedback and on-going support to product development teams for regulatory issues and questions.
Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
May mentor or supervise other RAS, as directed by manager.
Must Have: Minimum Requirements
7+ years of experience in regulatory affairs or the medical device industry
Experience working with medical device or pharmaceutical regulatory submissions
5+ years of experience in regulatory affairs, or the medical device industry with a Master's degree
Nice To Have
9+ years medical device industry experience
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) or Regulatory Affairs
Effective interpersonal skills
Effective team member
Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
Ability to effectively manage multiple projects and priorities.
Proficient computer skills
Experience with Class II/III medical devices (510(k), PMA, IDE)
Experience performing advertising and promotion reviews for medical devices
Medtronic product development experience
Clinical or statistical experience
Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
Project management skills
ABOUT MEDTRONIC: Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
EEO STATEMENT: It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Come for a job. Stay for a career.
Internal Number: 190002BY
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.