Regulatory Manager

Ft. Worth, TX 76116

Posted: 06/17/2019 Industry: Engineer Job Number: 8702

One of our top clients in the Ft Worth TX area is growing their Regulatory Team and is seeking a highly motivated individual to join their team. Great stable and growing company at the cutting edge of technology within its market!

Responsibilities:

•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
•Demonstrated ability to lead and work effectively with multiple stakeholders
•Ensures timely, clear communications to internal stakeholders on project status and issues
•Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines
•Meets individual goals as defined in the annual objectives
•Ability to excel in a matrixed environment and influence internal partners to achieve desired business outcomes
•Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments
•Engages stakeholders to co-create value, influence, align and lead internal and/or external stakeholders

Requirements:

•Bachelor’s Degree + 5 years of related experience (M.S.+2 yrs; PhD+0 yrs)
•Strong writing skills in the form of high-quality regulatory submission documents
•Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks
•Committed to drive efficiency while maintaining quality
• Demonstrated experience with U.S. FDA Class II and Class III medical device submissions.
• Demonstrated experience with EU Medical Device Directive 93/42/EEC and Class I, IIa, and IIb medical devices.

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: https://www.trcprofessionalsolutions.com/

Submit resume to heather.moore@trcstaffing.com

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