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Regulatory Affairs Advisor
Posted By: Seth Gold
Reference ID: goldcareers.com
Industry: Medical Devices
Job Type: Full Time
Location: Boston, MA US
Salary Offered: DOE
Experience Req: 5+ years in medical device regulatory
 
Description:

Global firm with $6+ Billion in annual sales seeks a Regulatory Affairs professional to assist in their Medical Device division. This area was founded in the past 10 years specializes in devices for Ophthalmology. This is an advisor/manager level role and the company offers growth opportunities along with a strong compensation and benefits program.

 

RESPONSIBILITIES:

The primary duties for this role are preparing regulatory assessments and plans for new products; supporting US as well as international product registrations; preparing and/or directing the preparation of submissions for product approval or clearance, specifically 510(k) pre-market notifications; developing and maintaining regulatory procedures; reviewing labeling, training and promotional materials; providing ongoing analysis of international medical device regulations.

While this description highlights certain aspects of the role, it does not fully encompass all of the duties and responsibilities.

 
 
Requirements:

A minimum of 8 years of previous regulatory experience with at least 5 of those years in Medical Devices including experience in preparing FDA 510(K) submissions; previous experience working with regulatory agencies; knowledge of medical device regulatory requirements (MHLW, MMD and other international regulations is a plus); RAC certifications a plus as well. BS degree or higher, preferably in engineering, science, health care or other related fields.

 
 
 
Keywords: regulatory affairs, medical devices, 510(K), MHLW, MDD, FDA, biotech, pharma, pharmaceutical
Job Record Number: 139
 
 
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