Regulatory Affairs Specialist II - Remote

Are you ready to make a meaningful impact in the world of medical devices and hearing technology Starkey is excited to announce an opening for an experienced Regulatory Affairs Specialist II. In this vital remote role you'll take charge of regulatory strategies ensuring our cuttingedge products meet compliance standards in global markets. You’ll collaborate with talented teams across departments like Quality Marketing Product Development and Manufacturing to seamlessly integrate regulatory requirements throughout the product lifecycle. Staying ahead of changing regulations maintaining technical documentation and ensuring compliance—including labeling—will be at the heart of what you do. If you're passionate about innovation and thrive in a dynamic environment we want to hear from you!

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 cuttingedge hearing health innovations industryleading research and development and not being afraid to push the edge of what’s possible.

We are headquartered in Eden Prairie Minnesota have over 5000 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.

Job Summary

This position is responsible for supporting all Regulatory affairs for medical devices and hearing related products. This

position will work with various departments across the organization such as Sales and Marketing to the Product

Development group with guidance from senior regulatory personnel throughout the product lifecycle. This position is

responsible for supporting activities that keeps Starkey current with changes to medical device regulations. This position

is also responsible for creating and maintaining the technical files for all medical devices and hearing related products.

Job Responsibilities

Market Access – Ensure market access of our products WorldWide

• Support assessing the acceptability of quality and clinical documentation for submission filling to comply with regulatory requirements for clinical trials marketing applications and corporate goals to secure submission approval
• Support labeling compliance before product release
• Coordinate 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 productassociated events are reported to regulatory agencies
• Participate in riskbenefit 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

Job Requirements

Education

• Fouryear degree in Science or Engineering.
• Master’s degree (MS MBA) preferred.

Experience

Minimum 4 years’ experience in related field required

Must Haves

Audit experience

Knowledge of EU MDR/FDA requirements

Regulatory Submissions

Compiling regulatory documentation (STeD DoC)

Regulatory assessments

Medical device labeling

Preferred To Have

International registration

UDI

Interaction with regulatory bodies

NPI/design controls

CAPA

Our Culture

• An experienced team built around a culture of professional growth and knowledgesharing
• 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

Salary And Other Compensation

The annual salary for this position is between $75460.00 to $102900.00/year. Factors which may affect starting pay within this range may include geography/market

skills education experience and other qualifications of the successful candidate.

Benefits

The Company offers the following benefits for this position subject to applicable eligibility requirements include medical insurance dental insurance vision insurance 401(k) retirement plan life insurance shortterm disability insurance longterm disability insurance employee assistance program hearing aid benefits PTO 6 paid holidays annually 2 floater days annually 1 volunteer service day annually paid paternity leave and tuition reimbursement.

This position is eligible for a bonus based upon performance results. There is no guarantee of payout.