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Medtronic

Senior Regulatory Specialist Coordinator, Advertising and Promotion Job at Medtr

Medtronic, Irvine, CA, United States, 92713

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Senior Regulatory Specialist Coordinator, Advertising and Promotion

Join to apply for the Senior Regulatory Specialist Coordinator, Advertising and Promotion role at Medtronic

We anticipate the application window for this opening will close on 6 Dec 2025.

At Medtronic you can begin a life‑long career of exploration and innovation, 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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In‑person exchanges are invaluable to our work. We’re 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

  • 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

  • Bachelor’s 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.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excluding PR) locations (USD): $93,600.00 – $140,400.00. 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.

Benefits for regular employees who work 20+ hours per week include health, dental & 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).

Benefits for all regular employees include 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, and Capital Accumulation Plan.

Regular employees are those who are not temporary, such as interns. Temporary employees may be eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Additional details are available on the Medtronic website.

Equality Statement

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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. Medtronic will consider 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.

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