Global Regulatory Affairs Specialist – MENA

Sonova Group; Santa Clarita (CA); Hybrid; USD 79,000 - 94,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401k with company match

Hearing aid discount

Tuition reimbursement

PTO & holidays

Job summary

Sonova Group is seeking an International Regulatory Affairs Specialist to drive regulatory strategies and submissions for the MENA region. The role collaborates with in-country teams to secure timely market access for products in Middle East and North Africa.

Required are a science/engineering background and 3+ years of related experience; Master’s is preferred. The role involves travel and a hybrid work model from Valencia, CA, with strong emphasis on risk assessment and post-market obligations.

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 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.

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.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory compliance

Communication

Microsoft Office

Salesforce

SAP

RIM platforms

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering/Regulatory Affairs

Tools

RegDesk

RIMSYS

Regulatory information systems

Job description

Sonova Group is seeking an International Regulatory Affairs Specialist to drive regulatory strategies and submissions for the MENA region. The role collaborates with in-country teams to secure timely market access for products in Middle East and North Africa.

Required are a science/engineering background and 3+ years of related experience; Master’s is preferred. The role involves travel and a hybrid work model from Valencia, CA, with strong emphasis on risk assessment and post-market obligations.