International Regulatory Affairs Specialist, MENA (Hybrid)

Sonova USA, Inc.; Valencia (CA); Hybrid; USD 79,000 - 94,000; Full time

Benefits offered by this job

Medical, dental, vision

401k with company match

PTO and paid holidays

Tuition reimbursement

Hearing aid discount

Job summary

Sonova USA, Inc. in Valencia, CA is seeking an International Regulatory Affairs Specialist to support regulatory strategies and submissions for Middle East and North Africa markets.

You will plan submissions, maintain registrations, and collaborate with in-country teams to ensure timely market access and ongoing product availability. The role requires a Bachelor’s in a scientific field (Master’s preferred) and 3+ years (5+ with Master’s) of international regulatory experience, with knowledge of

Qualifications

• Bachelor's degree in a scientific discipline or engineering.
• Master's degree in scientific discipline, engineering, Regulatory Affairs preferred.
• 3+ years International Regulatory Affairs experience (5+ with Master's).
• Experience with submissions and compliance for Class III medical devices preferred.
• Knowledge of regulatory pathways in Middle East and North Africa markets; ISO 14971/13485, labeling, clinical requirements, post-market obligations.
• Strong communication, organizational, project management, collaboration, and attention-to-detail skills.
• Experience with Microsoft Office, Salesforce, SAP, and 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

Strong communication

Project management

Attention to detail

Collaboration

Regulatory knowledge

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering or regulatory affairs

Tools

Microsoft Office

Salesforce

SAP

RIMSYS

RegDesk

Job description

Sonova USA, Inc. in Valencia, CA is seeking an International Regulatory Affairs Specialist to support regulatory strategies and submissions for Middle East and North Africa markets.

You will plan submissions, maintain registrations, and collaborate with in-country teams to ensure timely market access and ongoing product availability. The role requires a Bachelor’s in a scientific field (Master’s preferred) and 3+ years (5+ with Master’s) of international regulatory experience, with knowledge of