Associate II, Vigilance

Valencia, CA - Remote

Associate II, Vigilance

The Vigilance Associate conducts administrative tasks within the Vigilance Team according to well-defined guidelines.

Supports regulatory post market activities for Class III active implantable medical devices. Participate in activities to ensure compliance with global regulatory reporting requirements. Provide post market support for regulatory submissions, tenders, and renewals.

Responsibilities:

• Conduct in-depth assessments of product complaints to determine reportability in accordance with FDA and international competent authority requirements.
• Analyze, monitor and manage reportable events from identification through to closure.
• Prepare and submit medical device incident reports, ensuring accuracy, completeness, and adherence to FDA and country-specific requirements. Maintain thorough documentation of reporting decisions and justifications.
• Collaborate with cross-functional teams, including quality and clinical affairs, to gather and verify critical information required for reportable incidents to ensure all reporting requirements are met.
• Assist in the technical reviews and analysis of post market surveillance data required by regulatory agencies. Ensure completeness and accuracy of submissions to maintain compliance with product post market approval obligations.
• Support continuous improvement of post market systems and procedures by monitoring changes in regulatory requirements and updating procedures, databases and documentation accordingly.
• Maintain organized records of reportable events and incident reports. Support internal and external audits by compiling necessary documentation.
• Other duties as assigned.

Travelling Requirement: up to 20%

More about you:

• High School Diploma

Nice to have: BS in scientific discipline/ engineering equivalent

• Minimum of 2 years' experience in Regulatory Affairs for Class III active implantable devices.
• Excellent writing, proof reading and data management skills.
• English language/ proficient
• Proficient in Microsoft Office suite.
• Working knowledge of cloud-based systems.

Nice to have: Oracle, SAP and Salesforce 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 $25.76/hr - $38.65/hr. 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.