Principal Regulatory Affairs Specialist

22 Mar, 2021

Jobs

Principal Regulatory Affairs Specialist

Starkey Hearing Technologies
Eden Prairie, MN

Job Details

Description

Starkey Hearing Technologies is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Founded in 1967, Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. Starkey is the only American-owned provider of hearing technologies. The company has more than 6000 employees globally, operates 26+ facilities and does business in more than 100 markets worldwide.  Starkey’s product Livio AI was named to TIME’s list of the 100 Best Inventions of 2019.

Here’s a video about how Starkey is redefining the hearing healthcare industry, which features 13 employees: https://www.youtube.com/watch?v=Rujbz9DCoI8

 

We are seeking to add a Principal Regulatory Affairs Specialist 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.  You 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.  This position is responsible to keep current with all changes to medical device regulations to ensure Starkey products comply to all new or changing requirements, including labeling.  You will also be responsible for creating and maintaining the technical file for all medical devices and hearing related products.

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
  • Ensure market access of our products World-Wide
  • Identify Product Risk within product development (per project) and work with others to mitigate
  • Manage global Regulatory threats, changes and opportunities

You Will Need:

  • Education: Four-year degree in Engineering or Science.  Master’s degree (MS, MBA) preferred
  • Experience: Minimum 15 years with B.S. or related experience, or 13 years with M.S., or 10 years with PhD
  • Knowledge of GxPs (GCPs, GLPs, GMPs)
  • Knowledge of Quality Management Systems
  • Knowledge of World-Wide regulatory requirements
  • Knowledge of Import/export requirements
  • Knowledge of product marking requirements (by market)

 

#LI-JW1


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Learn more here

Job posted: 2021-03-22