Associate I, Vigilance

Remote | Valencia, CA

Advanced Bionics is looking for a Vigilance Associate I to support regulatory post-market activities for Class III active implantable medical devices. This role will support global regulatory reporting requirements and help ensure compliance with applicable regulatory requirements.

Responsibilities:

• Evaluate product complaints to determine reportability based on FDA and applicable country requirements.
• Generate and submit medical device incident reports in accordance with regulatory requirements.
• Manage reportable events through closure.
• Provide guidance regarding required content for reportable incidents.
• Assist with technical reviews and analysis of data required by regulatory agencies.
• Support updates to systems and procedures as regulatory requirements change.
• Maintain departmental databases and documentation.
• Participate in and document audits.
• Support regulatory submissions, tenders, and renewals.

More about you:

• High School Diploma required.
• Bachelor's degree in a scientific discipline, engineering, or equivalent preferred.
• Complaint handling experience is required.
• Highly organized, efficient, self-motivated, and detail-oriented.
• Excellent written and verbal communication skills.
• Strong writing, proofreading, and data management skills.
• Proficient in Microsoft Office and comfortable working with cloud-based systems.
• Experience with Oracle, SAP, and Salesforce preferred.
• Ability to travel up to 20%. 

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
• Company paid Short/Long-Term Disability coverage
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO, floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program
• 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: $64,000 - $81,000.

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.