Regulatory Affairs Specialist

Dear Candidate,

We at MAKRO delivers custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known life science organizations throughout United States. Our broad geographic reach, scalability and immense talent pool enable us to reliably meet the needs of enterprise-level clients. We thoroughly understand and believe that long lasting in-depth relationships with clients is an integral part in the business environment and equally important is the relationship with our candidates.

Our vision is to become a most reliable 'connector' between pharmaceutical, Biotechnology, Medical Devices companies and Talent pool i.e ' YOU '.

We have following opportunity currently available for you.

Regulatory Affairs Specialist (Women's Health)

Location: Marlborough, MA

Type: FullTime

Job Responsibilities:Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process. Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation. Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle. Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.

Required Skills: Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. 2 – 4 years Regulatory Affairs experience, medical industry experience preferred. Working knowledge of FDA and international regulations. General understanding of product development process and design control. General understanding of regulations applicable to the conduct of clinical trials. Ability to manage several projects. Proficiency with Microsoft Office.

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The most effective way of communication is via phone (973-481-0100 Ext: 3059). I appreciate if you forward your updated word formatted resume at ramesh.akkarapak@vernascientific.com for review before we speak.

** Makro is an INC 5000 company for 2007 and 2008
** Makro is a 3-time FAST 50 technology firm in NJ for 2005/2006/2007 (awarded by Deloitte)
** Makro is a 3-time FAST 500 technology firms in USA for 2005/2006/2007 (awarded by Deloitte)

MAKRO Companies:

 

Makro Technologies, Inc.

Vernascientific

Makrocare