Senior Regulatory Affairs Coordinator - Onsite

Position : Senior Regulatory Affairs Coordinator

Location : Irvine, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Clinical

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

JOB DESCRIPTION

Key Responsibilities:

• Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements.
• 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 new and renewal registrations, product and process changes, and labeling content.
• 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 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

Education and Experience:

• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience required