Title: Regulatory Affairs Coordinator III

Location: Irvine, CA (Hybrid) – Position is open to Fully Remote candidates

Note: This is a W2 contract role – C2C & 3 ^rd party candidates WILL NOT be considered

The Regulatory Affairs Coordinator will support US and EU regulatory submissions, exercising judgment to protect proprietary information, and track timelines and document milestone achievements. Additionally, they will;

• 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
• Handle other incidental duties, as assigned by leadership

Position Qualifications:

• 5-7 years of regulatory affairs experience, with astrong understanding of global regulations for new products or changes to relevant to medical devices, Class II, and/or Class III devices
• Ability to interact professionally with all organizational levels, and manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams, while representing the organization on specific projects; ability to build productive internal/external working relationships
• Proven expertise in Microsoft Office Suite, including Word, PowerPoint and Excel
• Strongwritten and verbal communication skills, and interpersonal relationship management skills
• Good problem-solving, organizational, analytical, and critical thinking skills; strict attention to detail
• Bachelor's Degree in Biology, Microbiology, Chemistry, Engineering, or other related field, including coursework, seminars, and/or other formal government and/or trade association training

Note: This is a W2 contract role – C2C & 3 ^rd party candidates WILL NOT be considered

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