Principal Regulatory Affairs Specialist at Medtronic in Irvine, California

Job Description:

Careers that Change Lives

We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.

Preference is for this position to be based in Irvine, CA.

A Day in the Life

The Principal Regulatory Affairs Specialist will be vital in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the concept phase through commercialization. The principal specialist is primarily responsible 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, and ensuring that our product technical documentation is current and accurate.

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 Bodies 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) from an accredited college or university required
• Minimum of 7 years of medical device regulatory affairs experience or advanced degree with a minimum of 5 years experience

• 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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.

A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many 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) here .

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