Specialist I, Regulatory Affairs
Sonova AG
Summary
Advanced Bionics is seeking an International Regulatory Affairs Specialist to support regulatory strategies and activities for product approvals and registrations across Middle East and North Africa (MENA) markets. This role is responsible for planning and executing regulatory submissions, maintaining product registrations, supporting regulatory compliance, and partnering with in-country representatives and cross-functional teams to help ensure timely market access and continued product availability.
Job description
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%
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Dependent Care Account
- TeleHealth options
- 401(k) Matching
- Company paid life insurance
- Company paid AD&D insurance
- Short-term disability coverage
- Long-term disability coverage
- Accident insurance
- Hospital indemnity coverage
- Legal assistance
- ID theft assistance
- Paid time off
- Paid holidays
- Paid parental bonding leave
- Employee Assistance Program
- Tuition reimbursement
- Hearing aid discount
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.