Senior Specialist, International (China) Regulatory Affairs

Sonova Group; Santa Clarita (CA); Sur place; USD 100 320 - 125 400; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

401k plan with company match

Tuition reimbursement

PTO and paid holidays

Employee Assistance Program

Résumé du poste

Sonova Group is seeking a Senior Specialist, International Regulatory Affairs in Santa Clarita, CA. This role focuses on supporting global regulatory activities for Class III medical devices, including obtaining and maintaining international approvals and compliance.

Qualifications include a bachelor's degree and 5-8 years of experience in medical device regulatory affairs. The role offers a hybrid work model, competitive salary range of $100,320 - $125,400, and benefits including medical insurance and PTO.

Qualifications

• 5-8 years of experience in pre-market and/or post-market medical device Regulatory Affairs.
• Experience with global regulations and maintaining certifications throughout the life of a medical device.
• Ability to work independently and manage multiple priorities.

Responsabilités

• Plan and execute global regulatory activities for Class III medical devices.
• Prepare international submissions and registration documentation.
• Support local in-country Regulatory Affairs affiliates for timely approvals.

Connaissances

Regulatory strategy

Writing and proofreading

Data management

Time management

Problem-solving

Microsoft Office proficiency

Formation

Bachelor’s degree or equivalent work experience

Outils

Agile PLM

SAP

Regulatory Information Management Systems

Description du poste

Valencia, CA

Senior Specialist, International Regulatory Affairs

Advanced Bionics is seeking a Senior Specialist, International Regulatory Affairs to support global regulatory activities for Class III medical devices. This role is responsible for helping obtain and maintain regulatory approvals in international markets, supporting local in-country Regulatory Affairs teams, preparing submissions, assessing regulatory impact of product changes, and ensuring ongoing compliance with applicable global regulations and standards.

Responsibilities

• Plan and execute global regulatory activities to obtain and maintain approvals in international markets, including LATAM, EMEA, and APAC
• Prepare international submissions, registration documentation, renewals, annual reports, and responses to regulatory authority requests
• Support local in-country Regulatory Affairs affiliates to help ensure timely approvals and continued product access
• Review product changes and assess regulatory impact on international regulatory strategies and submissions
• Provide regulatory input for sustaining and new product development projects, including country-specific requirements
• Support pre-market and post-market regulatory compliance activities for international product approvals
• Develop and maintain Regulatory Affairs procedures and support process improvement initiatives

More about you

• Bachelor’s degree required, or equivalent work experience
• 5-8 years of experience in pre-market and/or post-market medical device Regulatory Affairs
• Experience with global regulations and maintaining certifications throughout the life of a medical device
• Experience providing regulatory strategy and guidance for Outside U.S. and EU markets, including MENA, APAC, and LATAM
• Strong writing, proofreading, data management, time management, and problem-solving skills
• Ability to work independently, manage multiple priorities, and adapt when priorities change
• Proficiency in Microsoft Office; experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred

Travel

Up to 10% travel may be required.

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

What we offer

• 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
  • Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• 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)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform
• Plan rules/offerings dependent upon group Company/location.

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

How we work

At Sonova, we prioritize the well‑being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team‑customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the marketplace. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.