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.
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.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
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 findhere 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
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more