Associate I, Vigilance
Sonova AG
Summary
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.
Job description
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%.
Requirements
- 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%
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Dependent Care Account
- TeleHealth options
- 401(k) Matching
- Company Paid Life Insurance
- Company Paid AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Accident Coverage
- Hospital Indemnity Coverage
- Legal Assistance
- ID Theft Assistance
- Paid Time Off
- Floating Diversity Day
- Paid Holidays
- Paid Parental Bonding Leave
- Employee Assistance Program
- Tuition Reimbursement
- Hearing Aid Discount
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.