Sr Regulatory Affairs Specialist Neuro

We anticipate the application window for this opening will close on - 24 Nov 2025

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

This is an ONSITE opportunity at Medtronic Neurovascular located in Irvine California.

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 : 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. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its 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 and ensuring that our product technical documentation is current and accurate.

Provide strategic input and technical guidance on regulatory requirements for 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

Qualifications - External

Must Have; Minimum Requirements

Bachelors degree in Science or Engineering (or related field) from an accredited college or university required.

Minimum of 4 years of experience in medical device regulatory affairs

Or advanced degree with a minimum of 2years of experience in medical device regulatory affairs

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

Proficiency with Microsoft Office and software tools.

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

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.

Leads or compiles all materials required in submissions license renewal and annual registrations.

Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.

Monitors and improves tracking / control systems.

Keeps abreast of regulatory procedures and changes.

May direct interaction with regulatory agencies on defined matters.

Recommends strategies for earliest possible approvals of clinical trials applications.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

Salary ranges for U.S (excl. PR) locations (USD) : $92000.00 - $138000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification / education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week : Health Dental and vision insurance Health Savings Account Healthcare Flexible Spending Account Life insurance Long-term disability leave Dependent daycare spending account Tuition assistance / reimbursement and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees : Incentive plans 401(k) plan plus employer contribution and match Short-term disability Paid time off Paid holidays Employee Stock Purchase Plan Employee Assistance Program Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) and Capital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below :

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.

We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Required Experience :

Senior IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 92000 - 138000