Regulatory Affairs Specialist

At Medix we are extremely dedicated to our candidates, providing them with the best advice, support and direction during their job search. We work with all of our candidates personally to understand their skills and aspirations and best match them with opportunities that fit their goals. As we place contract, contract-to-hire and direct hire employment plans, we offer the flexibility to accommodate your schedule and needs.

Various US Cities (see overview for details)

Medix - Clinical Research

<p><strong>Clinical Research Professionals: Thank you for choosing to build your career in Research!&nbsp;</strong>With less than 2% unemployment in your field and a huge increase in clinical trials, your skills are in high demand!&nbsp;At Medix, we are passionate about positively impacting your job search by thoroughly understanding your skills, aptitudes, and aspirations while ensuring you are matched to an environment and opportunity that fits your goals. As a national organization, Medix places talent coast-to-coast within the Healthcare, Scientific and Information Technology industries.</p> <p><strong>&nbsp;</strong>Check us out on Social Media for the latest and greatest Clinical Research Opportunities. Please feel free to reach out directly OR 480-308-2175</p>

keywords: maintenance,openings,scientific,analysis,quality assurance,degree,experience,proficiency,knowledge



Overview: Responsibilities will include establishment, maintenance and optimization of the regulatory, quality and compliance function in a variety of clinical research environment; working with management to establish systems and controls and managing all regulatory, quality and compliance functions to help the company achieve its short and long term objectives.<br /><br />Current Openings:<br /> <ul> <li>Chicago, IL</li> <li>Seattle, WA</li> <li>San Francisco, CA</li> <li>Houston, TX</li> <li>Dallas, TX</li> </ul>
Responsibilities: <p>Responsibilities:</p> <ul> <li>Primary interface with Scientific Affairs, Clinical departments and CMO on regulatory issues providing expertise and support as required</li> <li>Deviations and CAPAs with regulatory impact</li> <li>Regulatory, Clinical and Scientific Standard Operating Procedure (SOPs)</li> <li>Assess current regulatory trends in industry (e.g. FDA guidelines, Industry standards and practices, 483/EIR findings, applicable regulations, e.g., HIPAA, FCPA) and report to management</li> </ul>
Requirements: <p>Requirements:</p> <ul> <li>Bachelors degree in Health or Life Sciences and 7 years in Regulatory Affairs experience or Masters degree and 5 years Regulatory Affairs experience in Life Sciences</li> <li>Minimum seven (7) years of experience in regulated industries with at least three (3) years in pharmaceuticals or medical device.</li> <li>QA and Regulatory Affairs experience required</li> <li>Expert knowledge of US and International (i.e., ICH) regulatory requirements regarding cGMPs, GCPs, ICH efficacy and quality guidelines, QSRs, 21CFR parts 11, 50, 54, and 312, and 45CFR part 54 and all other regulatory and guidance documents applicable to clinical research and imaging core labs.</li> <li>Demonstrate proficiency in all MS Office applications including Word, Excel, &amp; Power Point and internet software.</li> <li>Ability to provide quality control review to working documents and reports (interim or final versions) regarding complex technical, scientific or medical subjects.</li> </ul>