Regulatory Affairs Specialist III
Company: Kelly
Location: Waukesha
Posted on: May 16, 2022
Job Description:
Job Description We are a company that is focusing on medical
devices that enable earlier diagnosis and treatment. The sooner the
diagnosis-the more options for effective treatments. Our smart
screening devices and diagnostic tools empower clinicians and
health systems to identify and treat every patient with confidence,
shortening the path to assessment and then to care. The portfolio
includes products for vision screening & diagnostics which focus on
preventing blindness by facilitating early detection and treatment;
physical exam & diagnostic tools; diagnostic cardiology connected
electrocardiograph products; and respiratory care devices. The MDR
Regulatory Affairs (RA) Specialist is responsible to build and
deliver on regulatory strategies and technical documentation to
support regulatory submissions in US, Canada and EU for Front Line
Care medical devices. This individual will collaborate closely with
other regulatory experts in these markets or other regulatory
experts in other markets to achieve the best possible outcomes for
effective product registration. This individual is responsible for
a broad range of products in the Front Line Care portfolio. The MDR
RA Specialist supports new and sustaining product development teams
and will work closely with cross functional team members to assist
with regulatory issues related to such items as labeling, marketing
claims and testing requirements. The RA Specialist is an individual
contributor and reports directly to the US Manager of Regulatory
Affairs. Essential Duties & Responsibilities
- Plan, coordinate and prepare regulatory documents in support of
MDR
- Construct and manage EU MDR technical files
- Review product labeling including advertising and promotional
materials for compliance
- Manage registration plans through collaboration with global RA
peers
- Review and approve test compliance reports and associated
technical documentation
- Review scientific/engineering materials including protocols and
test reports
- Provide global performance and safety requirements as an input
to product design teams
- Provide regulatory assessment on proposed changes to marketed
devices
- Support international product registration regulatory
colleagues Education, Experience and Qualifications:
- Bachelor's degree is required. Engineering, biology, or science
related field preferred.
- Minimum 2 years' experience in regulatory affairs. Advanced
degree may be considered as partial fulfillment of experience.
- Proven ability to contribute creative yet practical solutions
to problems
- Strong cross-organizational collaboration with internal
stakeholders and external regulatory agencies
- Strong project planning, leadership, negotiation, and
presentation skills You should know: Your safety matters!
Vaccination against COVID-19 may be a requirement for this job in
compliance with current client and governmental policies. A Kelly
recruiter will confirm and share more details with you during the
interview process. 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, Waukesha , Regulatory Affairs Specialist III, Other , Waukesha, Wisconsin
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