Regulatory Affairs Spec

Join our dynamic team in Irvine, CA, a vibrant city known for its innovation and quality of life. We are seeking a dedicated professional to contribute to our Regulatory Affairs department. This hybrid position requires on-site presence for three days a week, allowing for a balance of collaboration and independent work.

• Plan, coordinate, and implement regulatory submissions for products requiring government approval.
• Demonstrate a working knowledge of healthcare-related regulations and an in-depth understanding of preparing submissions.
• Apply relevant regulations and statutes to advance product submissions of basic medium complexity.
• Contribute to the strategic direction of regulatory pathway development.
• Refine and conform preliminary data used in the submission process.
• Translate technical data and descriptions into reviewer-friendly content.
• Ensure that appropriate regulatory requirements for submissions are met.
• Interact with regulatory bodies to facilitate product approvals or clearance.

• In-depth experience, knowledge, and skills within the regulatory affairs field.
• Ability to apply knowledge and skills to a wide range of standard and non-standard situations.
• Work independently with minimal guidance, usually determining own work priorities.
• Act as a resource for colleagues with less experience.