Role Description Prepare submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements. - Support project teams as a regulatory specialist by providing input on regulatory requirements and reviewing documentation for compliance under guidance from senior staff. - Assist in preparing regulatory submissions (e.g. PMA supplements, EC marking applications, product registrations) to obtain approvals for commercial distribution. - Review product and manufacturing changes for compliance with applicable regulations and standards, escalating issues as needed. - Review and assess supplier change notifications for potential regulatory impact; coordinate with internal stakeholders to determine required actions and ensure compliance. - Coordinate and support responses to regulatory agency inquiries; may participate in meetings as an observer but does not serve as primary contact. - Contribute to the development and improvement of departmental policies and procedures through feedback and implementation support. - Support business efforts to comply with new and existing regulations and international standards. - Foster relationships across business units and functional groups to share best practices. - Support regulatory audits as required. Qualifications - Bachelor’s degree in a scientific discipline, engineering, or equivalent required; advanced degree (Engineering, Management, or related field) preferred. - Minimum of 2–3 years of regulatory affairs experience, with Class II or Class III medical devices required; experience with global regulatory frameworks (FDA, EU MDR, etc.) preferred. - Strong knowledge of regulatory requirements, standards, and submission processes, including FDA and EU regulations; experience supporting implantable medical devices preferred. - Demonstrated ability to work independently and collaboratively in a fast-paced, matrixed environment, managing multiple priorities and stakeholders effectively. - Excellent written and verbal communication skills, including technical writing and preparation of regulatory submissions; ability to communicate across organizational levels. - Proven problem-solving, analytical, and critical-thinking skills, with the ability to assess regulatory risk and respond efficiently to business needs. - Proficient in English required; proficiency in an additional language preferred. - A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova. Requirements - Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you! Benefits - Medical, dental and vision coverage* - Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts - TeleHealth options - 401k plan with company match* - Company paid life/ad&d insurance - Additional supplemental life/ad&d coverage available - Company paid Short/Long-Term Disability coverage (STD/LTD) - STD LTD Buy-ups available - Accident/Hospital Indemnity coverage - Legal/ID Theft Assistance - PTO (or sick and vacation time), floating Diversity Day, & paid holidays* - Paid parental bonding leave - Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) - Robust Internal Career Growth opportunities - Tuition reimbursement - Hearing aid discount for employees and family - Internal social recognition platform Company Description This role's pay range is between: $75,200/yr - $112,800/yr. This role is also bonus eligible. At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

• Help build and own a mature, scalable GRC framework to manage Garner’s regulatory risks, obligations, and internal policies • Serve as the internal point-person for the Revenue, Marketing, and other teams on day-to-day regulatory and compliance-related challenges and questions • Manage Garner’s ongoing compliance obligations, including its license application and renewal program and other required regulatory filings • Partner with the Product Team to provide guidance on new product initiatives and changes to existing products, ensuring that innovations remain compliant with applicable rules • Develop and maintain formal protocols for internal and external investigations, risk assessments, and incident response preparation • Provide generalist legal support on an as-needed basis

• Assisting with the coordination of the 340B Drug Pricing Program for all qualified entities throughout the WVU Medicine Health System. • Reviewing operating and regulatory compliance procedures and controls to ensure proper application of laws and requirements are met for continued eligibility for the 340B Program. • Conducting ongoing internal audit functions, data analysis, and operation review.

• Independently represent the PS&RA function on cross-functional project teams • Develop and execute regulatory strategies for cosmetics, personal care, and OTC products • Analyze and interpret regulatory data to provide strategic recommendations and influence project direction • Identify regulatory risks and mitigation strategies to support successful product launches • Maintain and update State and Federal reporting requirements • Prepare and review regulatory documentation including ingredient assessments, formula reviews, product dossiers, claims, packaging labels, marketing communication materials • Effectively communicate with internal teams and external partners • Lead cross-functional collaboration with R&D, Legal, Quality, and Marketing teams • Mentor junior team members and contribute to building regulatory capability across the organization • Represent the company in external forums and teach regulatory best practices