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Regulatory Affairs Specialist

Company: Kelly
Location: Tustin
Posted on: May 1, 2021

Job Description:

JOB TITLE: Regulatory Affairs 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 clinical studies and 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 organization as well as regulatory bodies. DUTIES AND RESPONSIBILITIES

  • Support and prepare documentation for regulatory submissions and registrations (FDA, EU, and Canada 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.
  • Support MDR transition project to maintain compliance.
  • Support post-market and vigilance reporting process.
  • 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 to Regulatory Affairs Manager. 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
    • Bachelor's degree (B.S.) from four-year College or University
    • Three (3) years minimum experience in regulatory affairs.
    • Current knowledge applicable regulations (including but not limited to): 21CFR related to medical devices, FDA Guidelines, Medical Device Directives (93/42/EC), MDR 2017/745, ISO 13485, ISO 14971, Canada Medical Device Regulations 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 (Word, excel) and Adobe Pro. For immediate consideration, please email resume directly to the recruiter #TJP2021_SPEC 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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ]]

Keywords: Kelly, Tustin , Regulatory Affairs Specialist, Other , Tustin, California

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