Sr Regulatory Affairs Specialist I

Starkey•Eden Prairie, MN

32d•$88,550 - $126,000•Hybrid

About The Position

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. Watch this video to see more of what sets Starkey apart. https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6 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!

Requirements

Four-year degree in Engineering or Science.
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, 21CFR820
Knowledge of Quality Management Systems required
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

Nice To Haves

Knowledge of World-Wide regulatory requirements desired
Knowledge of Import/export requirements desired
Knowledge of product marking requirements (by market) desired
Systems analysis skills desired

Responsibilities

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.
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