Indotronix Avani Group · 1 day ago
Regulatory Affairs Specialist
Irvine, CA
Contract
Onsite
Senior Level
7+ years expIndotronix Avani Group is seeking a Regulatory Affairs Specialist to support US and EU regulatory submissions. The role involves tracking timelines, documenting milestone achievements, and ensuring compliance with global regulations relevant to medical devices.
ConsultingMachine LearningSoftware
Hiring Manager
Ravi Teja
Responsibilities
Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Qualification
Required
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
7+ years of experience Regulatory Affairs required
Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Company
Indotronix Avani Group
Indotronix Avani Group is a consultancy that offers machine learning, cloud computing, software development and SaaS services.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mitch Meller
Chief Operating Officer
Recent News
2023-12-25
Company data provided by crunchbase