Senior Regulatory Affairs Coordinator - Onsite

Senior Regulatory Affairs Coordinator - Onsite

Location: Irvine, CA

Duration: 12 Months (Contract)

Total Hours/week: 40.00

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Clinical

Level of

Experience:

Senior Level

Employment Type: Contract on W2 (requires US Citizens, Green Card holders, EAD, OPT, or CPT)

• 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.
• Provide 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.

• 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 a scientific discipline (e.g., Biology, Microbiology, Chemistry).
• 5-7 years of experience required.