Senior Regulatory Affairs Specialist – Neuromodulation

Regulatory Affairs      ·       Remote in Minneapolis, MN       ·       Full time

Job Description

Senior Regulatory Affairs Specialist – Neuromodulation, Deep Brain Stimulation

Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. 

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.

Careers that Change Lives

 The Senior Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products (Class III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions, and negotiates their approval with the agencies. This position will support worldwide regulatory activities associated with innovative deep brain stimulation products.

A Day in the Life  / Responsibilities:

• Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Prepare FDA, European, and Canada submissions as required to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
• Provide support to currently marketed products. This includes reviewing labeling, engineering test reports, 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.
• Review only significant submission decisions/content issues with manager.
• Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams. 
• Provide feedback and on-going support to product development teams for regulatory issues and questions.
• Ensure personal understanding of all quality policy/system items that are personally applicable.  Follow all work/quality procedures to ensure quality system compliance and high-quality work.

Must Have: Minimum Requirements

• Bachelor’s degree
• Minimum 4 years of experience in medical device regulatory affairs 
• OR  Minimum 2 years of experience in medical device regulatory affairs, and an advanced degree
• Experience working with medical device or pharmaceutical regulatory submissions

Nice To Have 

• 7+ years medical device industry experience
• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams           
• Experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience with Class II/III medical devices (510(k), PMA, IDE)
• Experience with software development and cybersecurity applications
• Strong analytical skills related to comprehension of principles of engineering, physiology and medical device use.
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Computer skills; MS Office, MS Project, Adobe Acrobat and Agile 
• Experience performing advertising and promotion reviews for medical devices
• Experience with FDA and international regulatory agency requirements, ISO/GHTF standards
• Strong organizational skills and time management skills
• Strong negotiation skills and written/oral communication skills
• Clinical or statistical experience
• Medtronic product development experience

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)

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