What are the responsibilities and job description for the Regulatory Affairs Specialist position at Stellar Consulting Solutions, LLC?
Role: Regulatory Affairs Specialist
Location: Irvine, CA(Hybrid)
Duration: 12 Months(Contract#W2 with Medical Benefits)
Client: medical
Key Responsibilities:
• Support US and EU regulatory submissions (exercising judgment to protect proprietary information).
• Participate in assessing and collating regulatory impact and developing regulatory strategy
• Collaborate and approve change requests/change notifications.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for product and process changes.
• Other incidental duties assigned by Leadership.
Additional Skills:
• Coursework, seminars, and/or other formal government and/or trade association training required
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• 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.
• Strict attention to detail
• Ability to manage competing priorities in a fast paced environment.
Education and Experience:
• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience required
Kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!
Salary : $60 - $65