What are the responsibilities and job description for the Regulatory Affairs Specialist III position at Kelly?
Regulatory Affairs Specialist III (Milwaukee, WI)
$44.00/hour
Mon-Fri, Regular 8 hour Day Shifts
Job Description (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:
- BA 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.
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