Regulatory Affairs Lead — China & Taiwan Medical Devices

Sonova USA, Inc.; California; Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Paid holidays

Hearing aid discount for employees and

Tuition reimbursement

Job summary

Sonova USA, Inc. in Valencia (CA) seeks a Senior Specialist for International Regulatory Affairs to lead regulatory activities for China and Taiwan markets.

The role focuses on obtaining and maintaining approvals for Class III medical devices and coordinating with local RA representatives in a hybrid Valencia, CA setting. The ideal candidate has 5+ years in medical device regulatory affairs, strong writing skills, and experience with submissions and local testing for China/Taiwan.

Qualifications

• Bachelor's degree or equivalent work experience in a relevant field.
• 5+ years in pre-market and/or post-market medical device Regulatory Affairs.
• Experience preparing submissions and local testing for China and Taiwan.
• Knowledge of registration and standard requirements for China and Taiwan.
• Strong writing, proofreading, and documentation organization.
• Proficiency in Microsoft Office; SAP and Regulatory Information Management Systems preferred.
• English required; Chinese highly preferred.

Responsibilities

• Develop and execute regulatory activities to obtain and maintain approvals in China and Taiwan.
• Prepare regulatory submissions and registrations.
• Partner with local in-country Regulatory Affairs representatives to support timely approvals.
• Support in-country Regulatory Affairs representatives and essential product access.
• Review regulations and assess regulatory impact for registrations and changes.
• Create and update local SOPs and support RA procedures.

Skills

Regulatory affairs

Medical device regulation

Submissions & testing China Taiwan

English proficiency

Documentation & writing

Time management

Problem solving

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Agile PLM

SAP

Regulatory Information Management Systems

Job description

Sonova USA, Inc. in Valencia (CA) seeks a Senior Specialist for International Regulatory Affairs to lead regulatory activities for China and Taiwan markets.

The role focuses on obtaining and maintaining approvals for Class III medical devices and coordinating with local RA representatives in a hybrid Valencia, CA setting. The ideal candidate has 5+ years in medical device regulatory affairs, strong writing skills, and experience with submissions and local testing for China/Taiwan.