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1+ months

Regulatory Specialist

Kelly Services
Laguna Hills, CA 92653
**Kelly is actively recruiting for a Regulatory Specialist as a Direct Hire in the Greater Orange County Area, CA. 3-5+ years experience in Regulatory Affairs for Medical Devices is required. If you have CE Mark Submission experience and EU regulation experience those are both huge pluses.**


**Job Description:** Salary 100k


Regulatory Specialist


JOB SUMMARY


The primary responsibility of the regulatory specialist is to perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance. The position requires a high level of innovative thought and problem-solving skills. Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within the Clients organization as well as regulatory bodies.


DUTIES AND RESPONSIBILITIES


Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities)

IDE, PMA, 510(k), Design Dossiers, Technical Files.

Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.

Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.

Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.

Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

REPORTING


This position will report directly to the VP, Quality and Regulatory Affairs. Client Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.


JOB QUALIFICATION REQUIREMENTS


Bachelors degree (B.S.) from four-year College or University

Three (3) years minimum experience in regulatory affairs.

Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company products.

Knowledge and understanding of Quality and Regulatory concepts and application

Strong analytical, planning and organizational skills

Strong interpersonal and communications skills (oral & written)

Self-starter with ability to work independently under pressure and react quickly to changing priorities

Proficient in MS Office products.


If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-10 Expires: 2021-06-17

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Regulatory Specialist

Kelly Services
Laguna Hills, CA 92653

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