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Principal - Regulatory Affairs Specialist - Eden Prairie

Employer
Starkey
Location
Eden Prairie
Salary
Competitive

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Industry
Government and Public Services
Role
Other
Job Type
Long-Term
Hours
Full Time
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Starkey Hearing Technologies is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. The company has more than 5,000 employees, operates 24 facilities and does business in more than 100 markets worldwide.

We are seeking to add a Principal Regulatory Affairs engineer that will be responsible for all Regulatory affairs for medical devices and hearing related products. This includes the strategy of how products are viewed in our world-wide markets by various regulatory agencies. This position will work with various departments across the organization such as Sales and Marketing to the Product Development group to ensure all regulatory requirements are known and understood throughout the product lifecycle.

Our Culture:
  • An experienced team built around a culture of professional growth and knowledge-sharing
  • We celebrate innovation - finding creative ways to serve our customers better than anyone else
  • Global leader in the design, development and distribution of comprehensive hearing technologies
  • We serve with passion, purpose and excellence
  • Here's the bottom line - we work so people can hear!
    • You Will:
  • Serve as principal subject matter expert in at least one of following areas: Medical Device Regulation, Wireless Regulation, Safety Requirements, and/or Labeling Regulations.
  • Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information
  • Mitigate Risk
  • Identify and address issues early in the submission that could impact the product launch preparation process
  • Periodically scan changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, or Environmental
    • You Will Need:
  • Education: Four-year degree in Engineering or Science. Master's degree (MS, MBA) preferred
  • Minimum 15 years with B.S. or related experience, OR 13 years with M.S., OR 10 years with PhD
  • Knowledge of Quality Management Systems
  • Knowledge of World-Wide regulatory requirements
  • Knowledge of product marking requirements (by market)

    • #LI-NF1

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