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Job Profile
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Top Echelon Network
Director of Regulatory Affairs
Job Location: San jose, CA
Experience: 7-10 years of experience
We are seeking a highly qualified Regulatory Professional to work for a global leader in Healthcare Research, Medical Devices and Pharmaceuticals. Put your Regulatory and FDA expertise to work now in an exciting new opportunity!
This individual directs the regulatory affairs activities within various divisions of the organization to include interactions between the company and agents of the US FDA and health ministries outside of the US as required. Candidate will contribute to the development of strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development.
This position will ensure functional excellence in regulatory activities to achieve rapid worldwide clearance/approval/registration/licensure of company products with desired claims. Additionally, this individual plays an active role in external efforts to develop policies, guidance, and standards of strategic importance to the company.
The Director Regulatory Affairs facilitates complex problems requiring exercise of foresight and intellectual analytical skills while exercising independent judgment and discretion within broadly defined practices and policies. Candidate will be required to develop budgets and plans for the Divisions Regulatory Affairs Department.
Permanent position with an employee centered company offering great benefits, salary and relocation assistance.
The qualified candidate will have:
Bachelors but MS or PhD is preferred
7 years of experience in a regulatory affairs role
2 years minimum of management
Possess excellent communication, negotiation, and strategic assessment skills
Click Here to Apply
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