Senior Regulatory Specialist Coordinator, Advertising and Promotion

Medtronic Inc.•Irvine, CA

47d•Onsite

About The Position

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.

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 Haves

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

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

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)