Principal Regulatory Affairs Specialist – Neuromodulation

Regulatory Affairs     ·     Fridley, Minnesota, United States      ·       Full time

Job Description

PRINCIPAL REGULATORY AFFAIRS SPECIALIST – NEUROMODULATION

Medtronic is developing a new and exciting implantable electrical stimulation therapy to address a large unmet need of millions of patients globally. We are forming a high-performance team with entrepreneurial spirit to start this new therapy and new business. 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. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

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 Principal Regulatory Affairs Specialist supporting this new therapy will report directly to the Vice President of Regulatory Affairs for the Pelvic Health and Neuromodulation Operating Units (OUs).  This position will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.S. and major market submissions and obtaining approval to introduce this new Class III implantable electrical stimulation therapies worldwide.

These responsibilities are performed through the collaboration with various functions across the Operating Unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality and Marketing.

Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements.  The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new solutions based on experience and working collaboratively within the Regulatory department other business functions.

This position is based out of the Medtronic Fridley, MN office.

Position Responsibilities  

• Develop global regulatory strategies for a Class III implantable electrical stimulation therapy.
• Participate on the Product Development team and responsible for identifying submission deliverables, timelines, and strategic direction.  Reviews and approves technical documentation.
• Prepare FDA IDE and PMA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
• Negotiate with regulatory authorities to resolve questions/issues that arise prior to and during product submissions.
• Participate in the product change assessments and define regulatory impact of product changes in global markets.
• Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
• Interact directly with FDA and other major market regulatory agencies in support of product registration, approval, and commercialization.
• 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 for global commercialization.
• Provide feedback and on-going support to product development teams to assure timely resolution to regulatory issues and questions.

Must Have; Minimum Requirements 

• Bachelors degree required
• Minimum of 7 years of  medical device regulatory experience
• Or minimum  5 years of medical device regulatory affairs experience with Master’s degree

Nice To Have

• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical skills
• Extensive experience at formulating successful regulatory strategies that meet established approval timelines, while maintaining the highest level of quality
• Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, US and major market regulatory requirements, project management, and negotiations
• Regulatory experience with higher risk classifications (US Class III)
• Experience interacting with regulatory agencies
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Demonstrated ability to work well in dynamic and cross functional team environments
• Demonstrated collaboration and leadership skills in team setting
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Experience reviewing design specifications and other technical documents
• Excellent interpersonal and communication skills, both oral and written
• Working understanding of computer applications; proficient in Microsoft Office Applications
• Minimal overnight travel required

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)

Travel: Yes, < 25 % of the Time

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