Job Description

Regulatory Affairs Manager
Dallas-Fort Worth, TX


The Regulatory Affairs Manager will lead the local and international regulatory strategies in a pre and post-market setting. The Regulatory Affairs Manager will provide direct leadership to the existing business team and will be the company's main representative with the FDA, ISO and other regulatory bodies.  The Regulatory Affairs Manager will also support internal quality system initiatives and maintain facility registrations. This Direct Hire position provides excellent benefits and an opportunity to make an impact in one of the fastest growing industries! 

Requirements of the Regulatory Affairs Lead/Manager
  • Bachelor's Degree is required. 
  • At least 7 years of experiece in regulatory affairs within the BioMedical, Healthcare, Pharmaceutical or related Industry
  • Knowledge of applicable international regulations and standards (MDD, 13485 and CMDCAS)
  • Experience liasing with the FDA or other regulatory bodies 
  • Experience managing associates as a direct manager
  • Exceptional Communication, Organizational and Leadership skills
  • Proficiency in Microsoft Excel, Word, Access and Powerpoint
The company offers a tremendous benefits package to include an outstanding 401k plan matching 50 cents on the dollar up to 8% of your investment, and they also, whether you put $ in a 401k or not, invest a discretionary 7% into a 401k automatically for you. If you do the math on this, then that could be an EXTRA $5,000 or so per year of compensation/investments for you, from the company, on top of what you personally invest into your 401k (based on your salary and your personal 401k amount you invest that they'll match).  This is exceptional! 
  • Relo for the perfect candidate
  • 401K with match Medical / Dental / Vision / Flexible spending accounts
  • Discounted stock purchase program
  • Employee assistance program / Adoption assistance
  • Life insurance
  • Short term and long term disability insurance
  • Wellness programs
  • 3 weeks of vacation
  • 11 Paid Holidays
  • Paid maternity leave
  • Tuition reimbursement
  • Employee referral program
  • National employee discount programs

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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