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 cutting-edge 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 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 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/RESULTS Market Access Ensure market access of our products World-Wide 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 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 Education o Four-year degree in Science or Engineering. o 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 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 Salary and Other Compensation: The annual salary for this position is between $75,460.00 to $102,900.00/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, short-term disability ins