Specialist I, Regulatory Affairs (Valencia (CA), United States)

Responsibilities:

• Plan and execute regulatory activities needed to obtain and maintain approvals within Middle East and North Africa (MENA) markets
• Support end-to-end submissions, manage timelines, respond to deficiencies, and partner with in-country representatives as needed
• Provide support to local Regulatory Affairs affiliates who interact with regulatory authorities to help ensure timely approvals and continued product access
• Participate in sustaining and new product development projects by providing MENA regulatory requirements
• Review product changes and assess regulatory impact on submission strategy and market registrations
• Monitor new or amended regulations and support post-market regulatory compliance activities for assigned markets
• Update regulatory information management tools and support Regulatory Affairs procedures and process improvement activities
• More about you:
• Bachelor’s degree in a scientific discipline, engineering, or equivalent experience required
• Master’s degree in a scientific discipline, engineering, Regulatory Affairs, or equivalent experience preferred
• At least 3 years of International Regulatory Affairs experience with a Bachelor’s degree, or at least 5 years with a Master’s degree in a directly related specialty
• Experience with submissions and compliance for Class III medical device companies preferred
• Strong knowledge of regulatory pathways in Middle East and North Africa markets, ISO 14971, ISO 13485, labeling, clinical requirements, and post-market obligations
• Strong communication, critical thinking, organizational, project management, collaboration, and attention-to-detail skills
• Experience with Microsoft Office, Salesforce, SAP, and RIM platforms such as RegDesk or RIMSYS preferred
• Travel: Up to 10%
• A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
• Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!
• We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources
• What we offer:
• 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
• Plan rules/offerings dependent upon group Company/location.
• This role's pay range is between: $79,200 – $94,280 annually. This role is also commission eligible/bonus eligible.
• How we work:
• 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.