Principal Regulatory Affairs Specialist

Regulatory Affairs            ·           Irvine, California, United States            ·          Full time

Locations:   Irvine, California, United States

Job ID: 230006NA

Job Description

Careers that Change Lives

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: https://www.medtronic.com/us-en/e/neurovascular.html 

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, their unique backgrounds, and their 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.

Preference is for this position to be based in Irvine, CA however remote candidates will be considered.

A Day in the Life

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

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications
• Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, 510(k) submissions and 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 Body and serve as regulatory liaison on the project team throughout the product lifecycle.
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to 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

Must Have: Minimum Requirements

• Bachelors degree in Science or Engineering (or related field) required
• Minimum of 7 years of medical device regulatory affairs experience, or advanced degree with a minimum of 5 years medical device regulatory affairs experience

Nice to Have

• Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology. 
• RAPS Professional Certification (RAC)
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Detail-oriented
• Ability to be flexible with changing priorities
• Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
• Excellent written and oral communication, technical writing and editing skills.
• Excellent leadership, interpersonal and influencing skills.
• Ability to manage multiple projects and proficiency with Microsoft Office and software tools.

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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here. 

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.  

Min Salary: 112,400
Max Salary: 168,600
Travel: No

Please click here to apply.