MDR Regulatory Affairs Specialist (Remote)
Kelly is currently hiring for one of largest pharmaceutical companies in the world. We are seeking an experienced Regulatory Affairs MDR Specialist for a long-term engagement at one of our Global clients in Raynham, MA. This location can be remote (work from home).
This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly employees receive annual performance reviews.
- 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 guidance 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. 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.
To Apply: https://www.jobg8.com/Traffic.aspx?kuFVKk7EO7ci1rSnubCHawo