Regulatory Project Manager


Ontario, CA

Industry: Healthcare


5 - 7 years

Posted 152 days ago

  by    Bajrang Yadav

This job is no longer available.


Regulatory AffairsProject Manager to lead strategic regulatory projects focused on European Technical Files and the recently implement EU Medical Device Regulations.

Within these initiatives, the projects will span a variety of product families within the Patient Recovery business.




? 5+ years of related expereince along with 3+ years of project Management expereince Expert project management skills

? Must have direct experience with EU Medical Device Directives

? Must have experience in the medical device industry

? Drive multiple project work streams in parallel; ensure on-time completion of individual tasks and overall timely completion of project work streams

? Drive cross-functional business partners to a strategy and track progress

? Collaborate with in-function regulatory team members for document updates

? Coordinate & work with Regional Business Units (RBU)

? Participate in global regulatory strategy meetings

? Ensuring complaince with new & changing medical regulations

? Drive remote manufacturing site personnel to ensure timely execution of tasks and overall timely completion of project work streams

? Support development of business processes and procedures for execution of project work streams

? Promote creative solutions as needed

? Gather progress updates and conduct regular reporting to leadership stakeholders

? Maintain current regulatory databases and produce various reports as needed

? Provide basic regulatory guidance to cross-functional teams

? Review design control documents which include those associated with design inputs and design outputs


Primary Skills:


Secondary Skills:

?Ability to perform all assigned tasks, work independently, and complete work on schedule

?Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization

?Strong problem solving skills and efficient management of time and resources


Educational Qualifications