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Title

REGULATORY AFFAIRS SPECIALIST 

About the Organization Symmetry Surgical is dedicated to developing and delivering high-quality, innovative surgical instruments that meet clinicians' needs and improve patients' lives. We collaborate with healthcare providers around the world to provide medical devices that exceed customers' expectations and provide solutions for today's needs and tomorrow's growth.  
Location TN - Metropolitan Nashville - Antioch  
Full-Time/Part-Time Full-Time  
Shift First  
Exempt/Non-Exempt Exempt  
Description

JOB SUMMARY:

The Regulatory Affairs Specialist is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I and II medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a general resource to the Regulatory Affairs Department regarding documentation requirements supporting audits and requirements of the eMDR.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Communicate region-specific regulatory requirements to the Regulatory team leaders and assists with the regulatory registration strategies
  • Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions
  • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
  • Collaborate with International Sales and Marketing in prioritizing registration projects
  • Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data
  • Provide support to currently marketed products as necessary including input on change requests, etc.
  • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
 
Position Requirements

OTHER DUTIES & RESPONSIBILITIES:

EDUCATION:

  • Bachelor’s degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background – what you found has less education than the Reg Affairs Associate ((typically you start as specialist and work up through Associate))

EXPERIENCE:

  • Experience 1-2 years (either as an intern or fulltime) within a regulatory team.
  • BA in Life Science or Engineering

 
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. In view of the above, Symmetry commits to:

• Take affirmative action to employ and advance in employment qualified individuals regardless of race, color, religion, sex, sexual orientation, or any other legally protected status. Such action applies to all employment practices, including, but not limited to: hiring, promoting, layoff or termination, rates of pay or other forms of compensation, selection for training, tuition assistance, social and recreational programs.
• Base decisions of employment on criteria that ensures employees of both sexes shall have an equal opportunity to any available job that he or she is qualified to perform unless sex is a bona fide occupational qualification.
• Ensure all employment decisions are in accord with principles of equal employment opportunity by imposing only valid requirements for promotional opportunities.


 
Full-Time Part-Time None Specified 

This position is currently accepting applications.

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