Senior Global Regulatory Affairs Specialist (APAC)

Sonova Group; California; Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and paid holidays

Hearing aid discount for employees and

family

Job summary

Sonova Group is seeking a Senior Specialist, Regulatory Affairs in Valencia, CA. This hybrid role focuses on developing regulatory strategies for product approvals across APAC, EU, Canada, LATAM, and MENA, with PMA, 510(k), and organizing cross-functional activities.

The candidate will lead end-to-end submissions, ensure post-market compliance, and guide design controls, QA, and labeling throughout product development. Travel up to 10% may occur.

Qualifications

• Bachelor's degree in a scientific discipline, engineering, or equivalent experience required.
• Minimum of 8 years of global regulatory affairs experience within Class III medical device companies with a bachelor's degree, or 5 years with a master's degree in a directly related specialty.
• Hands-on experience with Class III medical device regulatory submissions, including PMA submissions, and regulatory activities throughout the product development lifecycle.
• Strong knowledge of international medical device regulations, including APAC regulatory requirements, EU MDR, and North American regulatory pathways.

Responsibilities

• Develop and execute regulatory strategies to obtain and maintain product approvals and registrations across international markets, including APAC, EU, Canada, LATAM, and MENA.
• Prepare and manage regulatory submissions, including PMAs, PMA supplements, 510(k)s, IDE applications, CE marking applications, and international product registrations.
• Provide regulatory guidance throughout the new product development lifecycle, including design controls, manufacturing processes, and sustaining engineering activities.
• Lead end-to-end regulatory submissions, manage timelines, respond to regulatory deficiencies, and collaborate with regulatory authorities and in-country partners.
• Support post-market regulatory compliance, including complaint reporting, vigilance activities, change assessments, and maintenance of existing product approvals.
• Monitor evolving international regulatory requirements and provide guidance on product labeling, testing, clinical requirements, and market-specific compliance.
• Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Development teams to support product releases, regulatory audits, and continuous process improvements.

Skills

Global regulatory affairs

PMA submissions

Project management

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree preferred (RAC)

Tools

RegDesk

RIMSYS

Job description

Sonova Group is seeking a Senior Specialist, Regulatory Affairs in Valencia, CA. This hybrid role focuses on developing regulatory strategies for product approvals across APAC, EU, Canada, LATAM, and MENA, with PMA, 510(k), and organizing cross-functional activities.

The candidate will lead end-to-end submissions, ensure post-market compliance, and guide design controls, QA, and labeling throughout product development. Travel up to 10% may occur.