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Senior Regulatory Labeling Specialist (Ad/Promo) - Hybrid
Senior Regulatory Labeling Specialist (Ad/Promo) - HybridMedtronic Plc • Irvine, CA, US
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Senior Regulatory Labeling Specialist (Ad / Promo) - Hybrid

Senior Regulatory Labeling Specialist (Ad / Promo) - Hybrid

Medtronic Plc • Irvine, CA, US
30+ days ago
Job type
  • Full-time
Job description

Job Opportunity At Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while 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 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 review meetings online and offline coordination with authors, reviewers / approvers to get content approved to support 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.
  • 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) : $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. 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 95,000+ 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 law. In 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 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.

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