Regulatory Affairs Operations Specialist

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands - Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron - we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Valencia, CA

Specialist, Regulatory Affairs Operations

Support Regulatory Affairs operations activities for Class III active implantable medical devices. Participate in activities to ensure compliance with global regulatory requirements and standards throughout the product lifecycle.

Responsibilities:

• Maintain an awareness of new and developing legislations, regulatory policy, regulatory guidance and international standards relating to Advanced Bionics.
• Monitor and communicate impact of relevant regulations, guidance documents, and international standards.
• Support business efforts to comply with new and existing regulations and international standards.
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
• Maintain and update assigned standard operating procedures, policies and work instructions.
• Support training, troubleshooting, and problem resolution for Regulatory Affairs systems and procedures.
• Foster relationships across business units and functional groups to share best practices.
• Identify opportunities for process improvement and participate in projects as a subject matter expert.
• Lead and support special projects including, but not limited to, data analysis and system implementations.
• Support UDI, Regulatory Agency Audits, and Field Action activities, as required.
• Other duties as assigned.

Travelling Requirement:up to 20%

More about you:

Education

• Bachelor's Degree in technical / scientific/engineering adjacent discipline.

Nice to Have

• Advanced Degree in scientific discipline / engineering / Management.

Work Experience

• Minimum of 4 years' experience in regulatory affairs, quality assurance, compliance, or project management for Class III active implantable medical devices.

Nice to Have

• 6+ years' experience in global regulatory affairs or compliance for Class III active implantable medical devices

Professional Competencies

• Good working knowledge of Global requirements, regulations and standards for Class III active implantable medical devices.
• Ability to work effectively in a matrix organization and partner effectively with remote stakeholders and peers
• Excellent writing, proof reading and data management skills.
• Excellent time management and problem-solving skills.

Nice to Have

• Experience using Continuous Improvement methodologies, for example Six Sigma and statistical tools for data analysis.

Language(s)/ Skills

• English/ Proficient

Nice to Have

• Proficient in any other language

IT Skills

• Proficient with Microsoft Office suite.
• Working knowledge of cloud based systems.
• Ability to quickly learn new computer technology software packages with minimal training

Nice to Have

• Oracle, SAP and Salesforce experience.
• Adobe InDesign experience.

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

Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone, please contact Sonova Human Resources.

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: $65,600/yr - $98,400/yr, compensation is based on skillset and location. This role is also 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.