Principal Regulatory Affairs Specialist

Medtronic • Spokane, WA

23h • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor to help develop regulatory depth and knowledge within the regulatory department staff. The Principal Regulatory Affairs Specialist will assist Regulatory Affairs management by overseeing the activities required to maintain products manufactured and/or distributed by Medtronic ENT are in full compliance with U.S. and all applicable international regulatory requirements 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. Travel requirement: 10-20%

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products.
• Exercise a leadership role and serve as a mentor to help develop regulatory depth and knowledge within the regulatory department staff.
• Assist Regulatory Affairs management by overseeing the activities required to maintain products manufactured and/or distributed by Medtronic ENT are in full compliance with U.S. and all applicable international regulatory requirements
• 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees