Manager- Regulatory Affairs

Ft. Worth, TX 76116

Posted: 10/04/2018 Industry: Project Manager Job Number: 000002843

TRC Professional Solutions seeks a Manager - Regulatory Affairs (Medical Device) for a full time role with a leading manufacturer located in Ft Worth Texas. Position offers competitive salary, bonus, benefits and relocation program.

Job Description
The purpose of this position is to monitor, search, identify, and assign new and revised external requirement documents from external and internal resources and recognize those that are applicable to company's products and processes..

• Review and comprehend material published by global regulatory bodies, standards committees, and industry best practice groups.

• Accurately taxonomize external requirements documents in terms of
document type and status, jurisdiction, and company's Subject Matter/Topic.

• Accurately assign external documents to the appropriate global company Subject Matter Expert(s) (SMEs) for review and assessment.

• Track the review and assessment by SMEs.

• Recognize salient information from external requirement documents and prepare company senior management executive summaries.

• Generate reports and prepare presentations for internal communication.

• Maintain the company's Core Standards List through regular monitoring of new or revised standards and communication with company's SMEs.

Minimum requirements
•Bachelor’s Degree or equivalent years of directly related experience (HS +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)

•The ability to fluently read, write, understand and communicate in English

•5 Years of Relevant Experience

•3 Years of Demonstrated Leadership

Candidate must have Medical Device industry experience

About TRC Professional Solutions

For over 10 years, professionals and employers have trusted TRC Professional Solutions with their business and careers. Year after year, Inavero’s Best of Talent and Staffing awards have been presented to TRC Professional Solutions for providing superior service and results to both our clients and job seekers. We create a different experience for our candidates and clients by remaining solely focused on bringing the right talent to the right opportunity, throughout every stage of our unique recruitment process. For more information, visit:

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