Senior Specialist, International Regulatory Affairs

Responsibilities

• Develop and execute regulatory activities necessary to obtain and maintain approvals in China and Taiwan
• Prepare regulatory submissions, including Product Technical Requirement documents, registration documentation, renewals, annual reports, and responses to regulatory authority requests
• Possess strong writing, proofreading, documentation organization, data management, time management, and problem-solving skills
• Partnership with local in-country Regulatory Affairs representatives to support timely approvals and continued product access
• Assess regulatory impact for product and process changes
• Create and update local SOPs and support Regulatory Affairs procedures and process improvement initiatives

Requirements

• Bachelor’s degree required, or equivalent work experience
• Minimum 5 years of experience in pre-market and/or post-market medical device Regulatory Affairs
• Experience working on submissions and local testing for China and Taiwan preferred
• Knowledge of registration and standard requirements for China and Taiwan preferred
• Experience assessing product and process changes for international registrations
• Proficiency in Microsoft Office; experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
• English required; Chinese highly preferred

Qualifications

• Strong writing, proofreading, documentation organization, data management, time management, and problem-solving skills
• Minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Benefits

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

Pay

This role's pay range is between: $100,320 - $125,400. This role is also commission eligible/bonus eligible.

Schedule

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova