Project Manager, Regulatory Affairs

  • location: Round Lake, IL
  • type: Contract
  • salary: $80 - $89.01 per hour
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job description

Project Manager, Regulatory Affairs

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!

 
location: Round Lake, Illinois
job type: Contract
salary: $80.00 - 89.01 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Project Manager to provide business and regulatory affairs leadership for a highly complex project supporting the transition from the EU MDD to the EU MDR and other regulatory needs across different global business units. This Project Manager will collaborate with cross functional stakeholders to drive to solutions/results in accordance with the project deadlines. This Project Manager will make commitments to businesses and manage stakeholder expectations about project deliverables during the program. Other activities include preparing or submitting documentation to authorities for medical device product submissions, assessing country impacts of regulatory changes and coordinating across business units with regulatory affairs leadership. This role will report to regulatory affairs leadership.
  • Accountable for core team performance, project schedule and on-time execution
  • Leads team in defining project deliverables and operating mechanisms
  • Provides clear direction on project to meet expectations of customers and business stakeholders
  • Interacts through project updates and reviews with all stakeholders ensuring effective ongoing communications across teams and stakeholders
  • Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies
  • Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
  • Work with cross functional teams to organize work and drive results
 
qualifications:
  • A minimum of an MBA/MS or Bachelor's with equivalent plus 3 years project management experience.
  • 8+ years of experience with regulatory affairs or regulatory affairs related projects
  • Strong experience working with MS Project, MS Excel, Word, Outlook, PowerPoint, and SharePoint
  • Direct experience with the EU Medical Device Regulations
 
skills: Project Management, MS-WORD, MS-EXCEL, MS-Project
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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