Specialist II, Regulatory Affairs

Select how often (in days) to receive an alert:

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.

161510

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:

• Requireda 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 200

Mb/sec download and 10

Mb/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
• Tele Health 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…