Medtronic Regulatory Labeling Specialist in Rice Creek, Minnesota
Regulatory Labeling Specialist
Rice Creek, Minnesota, United States
Mar 18, 2021
REGULATORY LABELING SPECIALIST
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers That Change Lives
The Regulatory Labeling Specialist supports planning and executing global regulatory labeling activities necessary to obtain and maintain regulatory approvals within the United States and Internationally. This position will support the regulatory labeling global strategy, review of advertising and promotional materials, requirements and labeling changes.
A Day In The Life
Act as a Promotional Labeling adviser and mentor to department members and project teams.
Advanced understanding and demonstrated leadership of label development, IFU development, change management systems, and global labeling regulations, requirements, procedures, and concepts.
Reviews advertising and promotional labeling materials for items, sales, and marketing literature to ensure all comply with related standards and labeling requirements
Monitors and interprets promotional labeling regulations/requirements and standards for medical devices
Becomes a subject matter expert on Promotional Labeling regulations requirements for both the US and EU
Provides audit support for promotional labeling policy and procedures
Assists in creating training to end users for proficiency of US and EU Promotional Labeling Regulations to include but not limit to Fair and Balance Concepts, Truthful, not Misleading concepts, Evidence and Substantiation and Special Rules, etc.
Participate on project teams, providing regulatory labeling strategy, timelines, and deliverables
Review Change Orders and assess regulatory labeling impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures
Develop and maintain regulatory affairs labeling procedures and process improvements
Comply with applicable FDA and international regulatory labeling laws/standards and the Code of Conduct
Keeps current on Labeling global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
Provide mentorship, training and support to other members of the department
Assist in keeping company informed of regulatory labeling requirements in the US and EU.
Other tasks, as assigned.
Must Have: Minimum Requirements (Must be evident on the resume)
Bachelors Degree required.
Minimum 2 years of US/EU medical device regulatory or medical device quality experience
Minimum 0 years of US/EU medical device regulatory experience with advanced degree
Nice to Have
Masters in Regularoty Affairs
Knowledge of FDA and EU requirements
Willingness to learn and stay abreast of labeling regulations for medical devices
Ability to build relationships with other departments (i.e. Marketing, Packaging, Development)
Strong written and oral communication, teamwork, and organizational skills
510(k) or PMA submission experience
Degrees in Legal or Regulatory Affairs preferred
Knowledge of FDA and EU Labeling Regulations, includes promotional labeling requirements
Strong negotiation skills and written/oral communication skills
Strong technical writing skills
Strong organizational skills and time management skills
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
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 Jobs