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Who we are

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change, 

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Valencia (CA), United States

Specialist II, Regulatory Affairs

161512

 

 

 

Valencia, CA        

 

Specialist II, Regulatory Affairs

Prepare submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements

 

 

Responsibilities:

  • Prepare and maintain global regulatory submissions (e.g., PMAs, PMA supplements, CE Mark applications, product registrations, annual reports, and change notifications) to obtain and sustain worldwide product approvals.
  • Partner with Clinical Research to prepare and support clinical investigation submissions (e.g., IDEs) and ongoing regulatory documentation for studies conducted in the U.S., Canada, and EU.
  • Manage and submit required reports for complaint handling and postmarket surveillance and vigilance activities, serving as lead for the Complaint Handling Group as needed.
  • Provide regulatory guidance to engineering and manufacturing teams to ensure compliance with global regulatory requirements throughout product design, development, and manufacturing.
  • Participate in engineering change order processes by reviewing and approving engineering and manufacturing documentation and changes.
  • Review and provide regulatory input on product labeling and marketing materials to ensure alignment with applicable regulations and standards.
  • Monitor evolving regulatory requirements and participate in cross-functional governance bodies (e.g., Safety Review Board and Patient Management Review Board), advising Regulatory Affairs leadership as appropriate.

 

 

More about you:

  • Required a bachelor’s degree, preferably in scientific discipline or engineering
  • Required 2 - 3 years of experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies, preferably under the Class III medical device environment
  • Proficiency with MS Outlook, Word, Excel, PowerPoint, Access and SQL
  • Good working knowledge of U.S. FDA, Canada and EU regulations and standards
  • Excellent interpersonal, communication and negotiating skills
  • RA certification (by Regulatory Affairs Professional Society) is a plus

 

 

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 all in 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: $75,200/yr - $112,800/yr. 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.

 

 

 

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 market place. 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.

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