Consultant – Financial Services
SAP Fioneer
Cloud
Regulatory Affairs Operations Specialist
Sonova Group
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $65,600 - $98,400 per year
Job Level
Mid-LevelSenior
Tech Stack
CloudOracle
About the role
- Support Regulatory Affairs operations activities for Class III active implantable medical devices. Participate in activities to ensure compliance with global regulatory requirements and standards throughout the product lifecycle. Maintain an awareness of new and developing legislations, regulatory policy, regulatory guidance and international standards relating to Advanced Bionics. Monitor and communicate impact of relevant regulations, guidance documents, and international standards. Support business efforts to comply with new and existing regulations and international standards. Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks. Maintain and update assigned standard operating procedures, policies and work instructions. Support training, troubleshooting, and problem resolution for Regulatory Affairs systems and procedures. Foster relationships across business units and functional groups to share best practices. Identify opportunities for process improvement and participate in projects as a subject matter expert. Lead and support special projects including, but not limited to, data analysis and system implementations. Support UDI, Regulatory Agency Audits, and Field Action activities, as required. Other duties as assigned. Travelling Requirement: up to 20%.
Requirements
- Bachelor’s Degree in technical / scientific/engineering adjacent discipline. Nice to Have Advanced Degree in scientific discipline / engineering / Management. Minimum of 4 years’ experience in regulatory affairs, quality assurance, compliance, or project management for Class III active implantable medical devices. Nice to Have 6+ years’ experience in global regulatory affairs or compliance for Class III active implantable medical devices Good working knowledge of Global requirements, regulations and standards for Class III active implantable medical devices. Ability to work effectively in a matrix organization and partner effectively with remote stakeholders and peers Excellent writing, proof reading and data management skills. Excellent time management and problem-solving skills. Nice to Have Experience using Continuous Improvement methodologies, for example Six Sigma and statistical tools for data analysis. Language(s)/ Skills English/ Proficient Nice to Have Proficient in any other language IT Skills Proficient with Microsoft Office suite. Working knowledge of cloud based systems. Ability to quickly learn new computer technology software packages with minimal training Nice to Have Oracle, SAP and Salesforce experience. Adobe InDesign 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 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.
