Regulatory Affairs Specialist I

Starkey is adding a Regulatory Affairs Specialist I on its dynamic Regulatory team. Are you passionate about innovation, medical device, and making a real impact? In this pivotal role, you'll support the regulatory process for cutting-edge medical devices and hearing-related products that improve lives around the world. As part of our collaborative and forward-thinking environment, you'll work closely with cross-functional teams-especially in new product development-to ensure our innovations meet global regulatory standards. You'll help maintain and develop technical documentation and stay ahead of evolving medical device regulations, ensuring Starkey remains a leader in hearing aid industry.

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

JOB SUMMARY DESCRIPTION

This 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 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.

JOB RESPONSIBILITIES

Regulatory Filing and Market Access:

• Support assessments and completion of documentation for submission fillings to comply with regulatory requirements
• 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 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

JOB REQUIREMENTS

Minimum Education, Certification and Experience Requirements

Education

• Four-year degree in Science or Engineering.
• Master's degree (MS, MBA) preferred.

Experience

• Minimum 1-2 years' experience in related field required

Knowledge / Technical Requirements

• 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

Competencies, Skills & Abilities

• 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

WORK CONTEXT

Working Conditions

• Standard office conditions
• Some travel is possible <10%

Equipment Operation

• Standard office equipment

Salary and Other Compensation:
The target rate for this position is between $56,210 to $76,650/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, short-term disability insurance, long-term 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.

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