Senior Regulatory Labeling Specialist (Ad/Promo) - Hybrid
MedtronicAbout the role
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.
A Day in the Life
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
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.
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