Senior Specialist, International Regulatory Affairs

About the Role A Valencia-based Senior Specialist, International Regulatory Affairs to support regulatory activities for Class III medical devices, with a primary focus on China and Taiwan market registrations. This role helps obtain and maintain regulatory approvals, prepares local submissions, supports in-country Regulatory Affairs representatives, and ensures compliance with pre-market and post-market requirements. What You'll Do

• 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
• Partner with local in-country Regulatory Affairs representatives to support timely approvals and continued product access
• Participate in sustaining and new product development projects to provide local regulatory requirements
• Review new or amended regulations and standards, and help keep the company informed of local regulatory requirements
• Review product and process changes and assess regulatory impact on international registration strategy and submissions
• Create and update local SOPs and support Regulatory Affairs procedures and process improvement initiatives What We're Looking For
• Bachelor’s degree or equivalent
• 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
• Strong writing, proofreading, documentation organization, data management, time management, and problem-solving skills
• Proficiency in Microsoft Office; experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
• English required; Chinese highly preferred Compensation & Benefits
• Salary range: USD 100,320 – 125,400 per year
• Benefits: Medical, dental, and vision coverage; Health Savings/Health Reimbursement accounts; 401k with company match; company-paid life/AD&D; STD/LTD; PTO and holidays; parental bonding leave; Employee Assistance Program; etc.
• Hybrid work model
• Equal opportunity employer and inclusive culture