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Regulatory Specialist Sr

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What they do

A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.

$105,184 / year median in California

+1% projected growth

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Job Description

Job Title:
Regulatory Specialist Sr Location:
San Diego, CA Pay Range:
$55/hr to $58/hr on W2 What's the Job? Ensure timely approval of new medical devices and continued approval of marketed products. Participate in continuous improvement activities, product plan development, and implementation. Develop and execute regulatory strategies, risk management, and policy assessments. Serve as a regulatory representative to cross-functional teams, providing expert guidance. Advise development and marketing teams on manufacturing changes, line extensions, and technical labeling. What's Needed? Minimum of 7 years of experience in Medical Device Regulatory Affairs. Extensive knowledge of US Medical Device Submissions and regulatory change assessments. Strong understanding of regulations, policies, and regulatory intelligence. Excellent communication and collaboration skills to work effectively across teams. Proven ability to manage multiple projects and meet deadlines in a fast-paced environment. Upon completion of waiting period consultants are eligible for: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account Health Flexible Spending Account Dependent Care Flexible Spending Account Supplemental Life Insurance Short Term and Long Term Disability Insurance Business Travel Insurance 401(k), Plus Match Weekly Pay If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!