מדעים/ביוטק

RA Project Manager

997178

תאריך עדכון

13/10/2021

תיאור המשרה

Plans, monitors, and manages internal projects from initiation through completion. Secures required resources and uses formal processes and tools to manage resources, budgets, risks, and changes. Manages projects to ensure on-time completion according to specifications and within
budgeted costs. Providing Regulatory leadership to new-product development teams, actively participating as the regulatory core functional
product team member. Develops sound global regulatory strategies for new and significantly modified medical devices. Provides global regulatory strategic input (including feasible alternatives and associated risks). 

Surveys the organization's country specific regulatory experts to obtain country-specific regulatory feedback during product development and at the request of the core functional product team. Compile information to provide to core functional product teams. 

Prepare documentation needed for registration worldwide or may oversee such preparation at the request of the organization's country specific regulatory experts. 

Reviews product and manufacturing changes related to products in-development for compliance with applicable regulations.  Participates in risk benefit analysis for regulatory compliance.  Monitors submissions under regulatory review; communicates timelines and review status to the core functional product team. Assesses proposed and new regulations and communicates new requirements to the organization. 

supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS) and other regulatory requirements. 

assists in SOP development and review. Provide regulatory input to product lifecycle planning. Provides leadership and guidance (including training) to other members of the RA staff. Assists with audits and inspections, if required.  

 EDUCATION AND EXPERIENCE  

Bachelor's degree in a technical discipline highly preferred 

Minimum 5 years regulatory experience;
 

Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions. 

Experience working in a broader enterprise/cross-division business unit model preferred. 

Ability to work in a highly matrixed and geographically diverse business environment. 

Ability to leverage and/or engage others to accomplish projects. 

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 

Ability to travel approximately 10%, including internationally. 

Ability to work independently with no oversight. 

Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.  

שלח קורות חיים
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