Kelly Services EUMDR Regulatory Affairs Specialist in Massachusetts
Kelly Science & Clinical is currently seeking a Remote EUMDR Regulatory Affairs Specialist for a long-term engagement with one of our Global Med Device clients out of Raynham, MA
This role is remote
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Execute projects in accordance with the cadence.
Support communication strategy to NPD staff to maximize understanding of expected impact from the MDR program to NPI.
Collaborate with stakeholders to develop and maintain project plans.
Create, monitor and analyze project risks and identify mitigation strategies.
Be responsible for all project communications to all cross-functional project stakeholders and communications include project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.
Report metrics of completion status to manager / Leadership Team.
Work with project team to identify and address critical path or roadblock issues.
Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.
Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.
To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable part.
Review and approval of documentation to support Technical Document to meet MDR requirements.
Participate in cross functional teams to discuss and revise documents to meet MDR requirements.
Support submission review process with Notified Body.
A minimum BA/BS Degree with at least 5 years of regulated medical device industry experience (or related) OR a master’s degree or higher with at least 6 years of regulated medical device industry experience (or related) is required
Knowledge of orthopedic implants a plus
Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus
Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
Familiarity with electronic submission preparation a plus
Excellent written and oral communication skills
Ability to handle multiple tasks and be detail oriented
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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
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