Regulatory Affairs Manager

Company Name:
Gabriele & Company
Regulatory Affairs Manager
Will manage and support a variety of regulatory projects that include preparing and submitting worldwide product registrations, developing regulatory strategies for international markets, coordinating recalls, field actions in product holds and participating in internal and external audits. This position requires ability to negotiate with regulatory agencies and develop strategies to improve compliance procedures.
This is an independent contributor key role with high visibility and a lot of latitude.
To Qualify the Selected Candidate Must Have
strong regulatory affairs experience within the medical device industry
significant experience with international submissions
location: Newton MA area
relocation package is available
compensation: the compensation package will reflect the candidates depth and breadth of regulatory compliance and submissions expertise.

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