Coord 3, Regulatory Affairs - Onsite

millenniumsoft • Irvine, CA

4d • Onsite

About The Position

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.

Requirements

• 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 interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience required

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1-10 employees