Senior Regulatory Affairs – Medical Devices (Hybrid)

Sonova; Santa Clarita (CA); Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Tuition reimbursement

Paid parental bonding leave

Employee Assistance Program

Job summary

Sonova is seeking a Senior Specialist, Regulatory Affairs in Valencia, CA. This hybrid role supports product approvals and registrations across international markets, with emphasis on APAC regulatory requirements for Class III devices.

The position emphasizes regulatory submissions, lifecycle management, and collaboration with Quality, Clinical, and Development teams to ensure compliance and timely market access.

Qualifications

• Bachelor’s degree in a scientific discipline or engineering.
• Regulatory experience in Class III medical devices with PMA experience is required.
• Familiarity with international medical device regulations (APAC, EU MDR, NA pathways).

Responsibilities

• Develop and execute regulatory strategies to obtain and maintain approvals across APAC, EU, Canada, LATAM, and MENA.
• Prepare PMAs, PMA supplements, 510(k)s, IDEs, CE marking and international registrations.

Skills

Regulatory affairs

PMA submissions

Class III medical devices

Cross-functional collaboration

Regulatory strategy

Regulatory guidance

Design controls & ISO 14971

Quality systems (ISO 13485)

Regulatory labeling & post-market

Education

Bachelor's degree in a scientific discipline

Master's degree or RAC preferred

Tools

RegDesk

RIMSYS

Job description

Sonova is seeking a Senior Specialist, Regulatory Affairs in Valencia, CA. This hybrid role supports product approvals and registrations across international markets, with emphasis on APAC regulatory requirements for Class III devices.

The position emphasizes regulatory submissions, lifecycle management, and collaboration with Quality, Clinical, and Development teams to ensure compliance and timely market access.