Sr Regulatory Affairs Specialist

Starkey is adding a Sr. Regulatory Affairs Specialist I on its Regulatory team. This position is primarily remote, but at times it will be required to be onsite at the global headquarters and other sites as needed. The Sr. Regulatory Affairs Specialist I position is responsible for supporting the Regulatory Affairs Department for all medical devices and hearing‑related products. This position will work with various departments across the organization with focus on new product development.

The Sr. Regulatory Affairs Specialist is responsible for supporting activities that keeps Starkey current with changes to medical‑device regulation and for creating and maintaining the technical files for all medical devices and hearing‑related products. Starkey offers full benefits, 4 weeks PTO, 401K match.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting‑edge hearing‑health innovations, industry‑leading research and development, and not being afraid to push the edge of what’s possible.

We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.

• 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!

• Market Access – Ensure market access of our products World‑Wide
  • Support assessments and completion of documentation for submission filings to comply with regulatory requirements
  • Support labeling compliance before product release
  • Support coordination of Homologation device delivery, testing & registration within new markets
  • Help to Compile, prepare, review and submit regulatory submission to authorities
  • Provide regulatory input to product lifecycle planning
  • Maintain records to comply with regulatory requirements
  • Support wireless requirements compliance throughout the product development process.
• Risk Management
  • Participate in Product Risk management within product development (per project) and work with others to mitigate
  • Ensure product safety issues and product‑associated events are reported to regulatory agencies
  • Participate in risk‑benefit analysis for regulatory compliance
• Manage global Regulatory threats, changes and opportunities
  • Support senior personnel in periodical scan of changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, and Environmental.
  • Some participation in professional associations, industry/trade groups and appropriate standards organizations
  • Other duties/responsibilities as assigned

Education: Four‑year degree in Engineering or Science.
Experience: Minimum 8 years experience with a four‑year degree, or 5 years experience with MS, or 2 years with Ph.D.

• Knowledge of GxPs (GCPs, GLPs, GMPs) required
• Knowledge of ISO 13485, MDSAP, EU MDR, Health Canada, 21
  
  CFR
  820
• Knowledge of Quality Management Systems required
• Knowledge of World‑Wide regulatory requirements desired
• Knowledge of Import/Export requirements desired
• Knowledge of product marking requirements (by market) desired

• Strategic Planning and organizing
• Written and verbal communication
• Presentation skills
• Communicate with internal stakeholders and regulatory authorities
• Prepare applications and regulatory documentation
• Review and assess regulatory submissions
• Utilize electronic submission techniques
• Critical thinking and problem solving
• Good attention to detail
• Systems analysis skills desired

The target rate for this position is between $88,550 to $126,000/year.…