International Regulatory Affairs Specialist – MENA

Sonova Group; California; Hybrid; USD 79,000 - 94,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k with company match

Life/AD&D insurance

Paid time off and holidays

Job summary

Sonova is seeking an International Regulatory Affairs Specialist to drive regulatory submissions and market access in the MENA region. You will plan strategies, manage timelines, and collaborate with local affiliates to ensure timely product registrations and ongoing compliance across diverse markets.

The role requires strong knowledge of ISO standards, post-market obligations, and cross-functional teamwork, with up to 10% travel.

Qualifications

• 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 MENA markets, ISO 14971, ISO 13485, labeling, clinical requirements, and post-market obligations.

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.

Education

Bachelor’s degree in science/engineering

Master’s degree in science/engineering/Regulatory Affairs

Tools

Microsoft Office

Salesforce

SAP

RIM platforms (RegDesk/RIMSYS)

Job description

Sonova is seeking an International Regulatory Affairs Specialist to drive regulatory submissions and market access in the MENA region. You will plan strategies, manage timelines, and collaborate with local affiliates to ensure timely product registrations and ongoing compliance across diverse markets.

The role requires strong knowledge of ISO standards, post-market obligations, and cross-functional teamwork, with up to 10% travel.