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Principal Regulatory Affairs Specialist - Ad Promo (remote)

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Posted 2 months ago United States Salary undisclosed
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Job Description


Pelvic Health & Gastric Therapies is part of the Neuroscience Portfolio. Our therapies treat patients suffering from incontinence-related conditions with our sacral neuromodulation (SNM) systems InterStim™ II and InterStim™ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™. We also treat patients suffering from gastroparesis with our gastric electrical stimulation system called Enterra™. Medtronic and physician-partners pioneered SNM therapy more than 25 years ago. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic Click Here

Careers That Change Lives

In this exciting role as the Pelvic Health Principal Regulatory Affairs Specialist, you will be responsible for supporting our customers needs by working closely with marketing and education to develop and maintain training, advertising and promotional materials and other related materials for Pelvic Health and Gastric Therapies products and therapies while ensuring FDA regulation compliance.

Location: Fridley, MN preferred; Open for Remote

Ability to travel up to 25%

A Day in the Life

Responsibilities may include the following and other duties may be assigned.
  • Apply regulatory and therapeutic area knowledge to marketing objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
  • Support new product development regulatory lead as a consultant on advertising and promotional requirements and best practices.
  • Support development and maintenance of product and therapy claims / evidence roadmaps
  • Provide internal training to regulatory affairs and other stakeholders as needed on advertising and promotion concepts.
  • Review and approve advertising, promotional and educational materials for compliance with regulatory requirements.
  • Interface with Medical Affairs on questions regarding unapproved uses.
  • Maintain current knowledge of industry and regulatory requirements, guidance and trends related to advertising and promotion. Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters and by attendance of appropriate FDLI, DIA and other industry/FDA meetings.
  • Maintain awareness of competitive activities.
  • Team with business unit Regulatory Affair Specialists to share best practices related to advertising and promotion and drive consistency across reviewers.
  • May also support regulatory review of clinical study / documentation and clinical /regulatory strategy development in support of claims.
  • May also provide support to currently-marketed products as necessary. This includes reviewing labeling, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
  • May mentor or supervise other RAS, as directed by manager.

Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 7 years of medical devcie regulatory affairs experience
  • Or advanced degree with a minimum of 5 years medical device regulatory affairs experience

Nice to Have (Preferred Qualifications):
  • Experience working with medical device or pharmaceutical regulatory submissions
  • Experience performing advertising and promotion reviews for medical devices or labeling [LK3] requirements
  • 9+ years industry experience
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Effective interpersonal skills
  • Effective team member
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities.
  • Proficient computer skills
  • Experience with Class III medical devices (PMA, IDE)
  • Medtronic product development experience
  • Clinical or statistical experience
  • Strong negotiation skills and written/oral communication skills.
  • Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
  • Project management skills and ability to manage multiple priorities

About Medtronic

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. Let's 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)

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.

Learn more about our benefits: benefits.medtronic.com

This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here.