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Senior Regulatory Specialist Coordinator, Advertising and Promotion
Senior Regulatory Specialist Coordinator, Advertising and PromotionMedtronic • Irvine, California, USA
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Senior Regulatory Specialist Coordinator, Advertising and Promotion

Senior Regulatory Specialist Coordinator, Advertising and Promotion

Medtronic • Irvine, California, USA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

We anticipate the application window for this opening will close on - 8 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

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

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

Support review of advertising and promotional material to ensure that it meets all medical legal and regulatory (MLR) process requirements.

Facilitate online and offline review meetings with authors reviewers / approvers to ensure content approval that supports business needs.

Act as SME for Neurovascular Ad Promo process providing guidance to authors and reviewers on regulatory and internal policy requirements.

Support the preparation of US and International promotional labeling material including the creation of a claims matrix database and claims objects.

Lead AI / ML adoption in content and claims management to support automation and enhance process efficiency.

Drive the pending review / approval requests for Ad Promo and work with reviewers to push the approvals in a timely fashion.

Create reports & metrics to provide visibility to management on cycle times of review / approval

Process improvement : work with a cross-functional team to map the process identify bottlenecks provide solutions and author new process documents

Monitor changes and compliance with applicable FDA and international regulatory laws / standards and the Medtronic Code of Conduct

Provide training support for new authors asset owners and reviewers / approvers

Facilitate review / approval system changes and user support

Qualifications

Must Have : Minimum Requirements

Bachelors degree in science communication or a healthcare-related field

4 years of medical device experience including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling or an advanced degree with 2 years experience

Nice to Have :

US and International medical device industry experience in Advertising & Promotional labeling

Proficiency with Veeva PromoMats Ad Promo / MLR claims and material review and approval systems

Excellent communication & organizing skills

Knowledge of FDA EU and TGA requirements

Knowledge of Neurovascular brain therapies

Experience of working with 510(k) and / or IDE and / or PMA devices

Product Labeling requirements and standards

Technical Writing experience

Systems Knowledge such as content management systems document management and workflow design

Business system analysis

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) : $93600.00 - $140400.00

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 : 93600 - 140400

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