What are the responsibilities and job description for the Project Manager position at Kelly?
Full-Time Contract Role
$50-60/hr
Seeking a Regulatory Affairs professional with global/MDR or MDD (Medical Device Directive) labeling experience
JOB DESCRIPTION:
In collaboration with cross functional teams, the incumbent provides guidance and subject matter support to RA project teams to facilitate regulatory compliance for EU MDR (EU Medical Device Regulation) in the most effective risk-based method. Provides leadership and guidance and subject matter support to offshore and onshore project contractors.
Responsibilities:
- Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key EU MDR labeling strategies and initiatives.
- Ensure project teams and business objectives and deliverables are aligned with project regulatory labeling strategy
- Lead group of regulatory professionals in labeling gap assessments to EU MDR requirements and the further development of labeling requirements documents per MDR project timelines
- Provide direct supervision and mentoring of project team members during the project. Provide project performance feedback to the team members supervisor/manager
- Assist in the formulation and execution of regulatory labeling strategies/ project plans
Qualifications: BA degree in Biological Sciences, engineering, or related field preferred
- Five or more years experience in medical device Regulatory Affairs. Direct experience with global device labeling will be an advantage.
- Minimum of five years professional experience managing people or projects.
Shifts
Mon-Fri w/ the current hybrid model in the office
8 hr shifts
Tues - Thurs 9am-5pm
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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