Medtronic · 2 days ago
Principal Regulatory Affairs Specialist
Spokane, Washington, United States of America
Full-time
Onsite
Senior Level, Lead/Staff
$118K/yr - $178K/yr
5+ years expMedtronic is a global leader in healthcare technology dedicated to alleviating pain and restoring health. The Principal Regulatory Affairs Specialist will lead the development and implementation of regulatory strategies to ensure compliance with U.S. and international regulations for medical devices, while mentoring staff and overseeing product registration activities.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company
Interpret new and existing regulatory requirements as they relate to Medtronic ENT products and initiate actions to assure compliance to these regulations
Participate as the regulatory representative on new product development/modification project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release
Lead submission activities for devices in gaining required clearances/approvals through the processes of IDE’s, 510(k)s, PMA’s, CE marking and combination products
Review change orders and assess regulatory impact of product changes
Review labeling, training, promotional and advertising material
Represent the organization on cross-business and cross-geography working groups to execute objectives of the Regulatory Council
Have input to and influence the development of regulatory requirements through work with regulatory bodies, industry groups and through coordinated efforts with corporate Medtronic
Provide support for acquisitions, including due diligence and post-acquisition assessment and education
Support the development and implementation of regulatory education and training across the business
Assist with the development and implementation of department policies and procedures
All activities must be performed in compliance with the Quality System
Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
All other duties as assigned
Qualification
Required
Bachelor's Degree with a minimum of 7 years of relevant experience or an advance degree with a minimum of 5 years of relevant experience
7+ years with Bachelor's Degree, medical device experience, and work experience in regulatory affairs
5+ years with Master's Degree, medical device experience, and work experience in regulatory affairs
Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU
Preferred
Bachelors degree in science, engineering, healthcare or related field
10+ years with Bachelors Degree, medical device experience, and work experience in regulatory affairs
8+ years with Masters Degree, medical device experience, and work experience in regulatory affairs
In-depth knowledge of U.S. and EU regulations and a working knowledge of key industry standards applicable to a medical device manufacturer, with functional understanding of international device regulations
Understanding of medical electrical equipment and their respective regulations
Understanding of combination products and their respective regulations
Knowledge of Good Manufacturing Practices
Knowledgeable in the due-diligence evaluation process of companies and/or product acquisition
Excellent written and oral communication skills and good presentation skills
Proficiency in MS Word, Excel and PowerPoint
Excellent organization and multi-project management skills and attention to detail
Must have high tolerance to ambiguity
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
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