Regulatory Manager

Ft. Worth, TX 76116

Posted: 08/14/2019 Industry: Project Manager Job Number: 10214

TRC Professional Solutions seeks a Regulatory Manager for a full time role with a leading manufacturer located in Ft Worth Texas. Relocation is available for right candidate!

Position offers competitive salary, bonus, benefits and relocation program. Great opportunity to be on the leading edge of new technology. Candidate must have FDA submission authoring experience as well as PMA device and class III experience.

Job Description
The Regulatory Manager is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product), working independently.
Leads close collaboration with internal stakeholders and supports multiple projects.
Identifies and executes non-project related ""regulatory excellence"" activities.
Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes
In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute
Provides high quality regulatory support for assigned products/projects
Partners with internal and external stakeholders (e.g., regions, Health authorities) to align on an optimized regulatory strategy in order to achieve business objectives.
Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments
Develops documents that are clear, concise, and complete to facilitate reviews/approvals
Develop and manage global regulatory strategies to maximize the value of the products/projects

Minimum requirements
Bachelor's Degree (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
5 years of directly related 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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