Specialist II, Regulatory Affairs

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 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: $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.