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Senior Associate/ Associate, Regulatory Operations

MR - Klein Hersh International-Boston, MA, 02217

Senior Associate/ Associate, Regulatory Operations Our client is an entrepreneurial pharmaceutical company focused on the development of medicines to target important human needs. They are experiencing significant growth and recently received positive results from a phase III trial for their lead compound. This is a great opportunity to join a company that offers potential for you to leverage your experience and take your career to the next level while working with a world-class drug discovery team. Job Responsibilities: - Assist with the development and implementation of systems and proced...
 

Regulatory Affairs Associate Jobs in Boston, Massachusetts Jobs

Aerotek | Boston, MA, 02108 | >5
An Aerotek client, a leading medical device manufacturer, is seeking a Regulatory Affairs Associate. The RAA will be preparing submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of Endoscopy products. Will provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Will act as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulator...
Covidien | Boston South, MA, 02048 | 5-7
Provides quality and timely support to obtain marketing clearance/approval for new products; devices/drugs, drug-device combinations. Maintains marketability of existing products. Providing assistance in supporting the process of meeting requirements established by US FDA and international governmental agencies in introducing vascular medical devices to market. * Planning and preparing PMA and 510K FDA submissions. * Reviewing Change Orders and assessing the regulatory impact of product changes on US, European, and International regulatory strategies. * Supporting post-market regulatory com...
 
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