We anticipate the application window for this opening will close on - 3 Oct 2025

 

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

SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR
Onsite Position Located at Our UCI Facility with a Minimum of 4 Days Onsite

In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at: Medtronic Neurovascular.

Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Join a diverse team of innovators who bring their worldview, unique backgrounds, and 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 Lives

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include:

• Reviewing changes to ensure that regulatory requirements continue to be met.
• Documenting “no file” decisions.
• Reviewing promotional materials.
• Submitting product changes and annual reports.
• Ensuring that our product technical documentation is current and accurate.

A Day In The Life

• Provide strategic input and technical guidance on regulatory requirements for product modifications.
• Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, and 510(k) submissions, as well as technical documents to support CE mark/MDR submissions.
• Manage multiple projects and prioritize tasks to meet project schedules.
• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities.
• Communicate with regulatory agencies and Notified Bodies, serving as the regulatory liaison on the project team throughout the product lifecycle.
• Review promotional and advertising materials.
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.
• Create or revise departmental procedures to improve operations or reflect changing regulatory requirements.
• Participate in internal and external audits as needed.
• Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements.
• Perform other duties as assigned or required.

To Be Successful in This Role

• Medical Device Experience: Minimum of 4 years of relevant experience in medical device regulatory affairs.
• 510(k) Submission Experience: Proven history of successful 510(k) submissions or at least supporting US 510(k) filings.
• EU MDR Knowledge: Solid experience or knowledge of EU MDR requirements and submissions.
• Education: Bachelor’s degree in Science or Engineering (or related field) from an accredited college or university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus.
• Regulatory Knowledge: Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology.
• Interpersonal Skills: Ability to effectively communicate and interface with project team members and contribute to the overall success of the team.
• Detail-Oriented: Strong attention to detail with the ability to manage multiple projects and changing priorities.
• Technical Skills: Proficiency with Microsoft Office and relevant software tools, as well as excellent written and oral communication, technical writing, and editing skills.

Must Have: Minimum Requirements

• Bachelor’s degree in Science or Engineering (or related field) from an accredited college or university required.
• Minimum of 4 years of relevant experience in regulatory affairs, or an advanced degree with a minimum of 2 years of experience in medical device regulatory affairs.
• This is not a remote position.

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