Regulatory Affairs Specialist
Posted on: May 1, 2021
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
- 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
- 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
- Bachelor's degree (B.S.) from four-year College or
- 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
- Strong analytical, planning and organizational skills
- Strong interpersonal and communications skills (oral &
- 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
Didn't find what you're looking for? Search again!