The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Medical Device, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
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.
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.
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!
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)
Internal Number: PRINC03268
About Starkey Hearing Technologies
Starkey Hearing Technologies is a world leader in the design, development and distribution of comprehensive hearing solutions. We believe in using superior hearing technology to create meaningful connections between people and their worlds.
Connections are also created between Starkey Hearing Technologies and our employees. Review the benefits of employment at Starkey Hearing Technologies to see what makes this a unique and exciting place to work.