Regulatory Project Manager

Larsen & Toubro  •  Ontario, CA

5 - 7 years experience  •  Healthcare

Salary depends on experience
Posted on 06/22/18 by Bajrang Yadav
Larsen & Toubro
Ontario, CA
5 - 7 years experience
Healthcare
Salary depends on experience
Posted on 06/22/18 Bajrang Yadav

Overview:

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.

 

Skills:

 

? 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

BE/BS 

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