[jsfg_cinti] Director of Regulatory - Indianapolis

      Job Title Director of Regulatory 
      Job ID: EMPS0001 
      Company: Engineering Systems Search 
      Location: Indianapolis, Indiana USA 
      Salary: $75000 - 110000 
      Industry:  
      Function:  
      Name:  
      Phone: 972-774-0888 
      Fax: 972-934-1345 
      Email:  
      Description:   
      Reporting to the Executive Director, Corporate Regulatory, the Director 
of Regulatory Affairs manages and coordinates facility quality and regulatory 
strategies and systems to assure that applicable local, national, and 
international requirements are met. The incumbent, in conjunction with the 
appropriate managers and department heads at the corporate and local level, 
defines the policy for determining appropriate, comprehensive and effective 
quality and regulatory compliance. The Director, Regulatory promotes a strong 
positive regulatory profile. 
      Requirements:   
      Must Have The Following Skills/Qualifications 1. A minimum of 10 years in 
medical device regulatory and quality functions in a management role 2. Strong 
technical background in devices/applications highly desirable. 3. Demonstrated 
success related to development and implementation of pre-clinical and clinical 
strategies, implementation of facility regulatory and quality systems, and 
assuring compliance to all applicable regulations 4. Authoritative knowledge of 
current US and International regulations and guidelines. 5. Strong written and 
verbal communication skills to all organizational levels. 6. Excellent 
interpersonal management skill 7. Self-motivated and flexible to changing 
schedules 8. Able to view processes from a systems perspective and interpret 
details that impact the overall system 9. Auditor qualifications a plus 
Education and/or Experience 1. Minimum 10 years of direct quality and 
regulatory management experience in medical device industry is required. 2. 
Minimum of BS degree in scientific discipline, preferably life sciences, 
biomedical, or other engineering science. MS or PhD a plus 3. Proven track 
record of clinical study oversight and management 4. Demonstrated record of 
managing people and project 5. Demonstrated record of working on project teams 
and multitaskin 6. Previous experience in risk management processe 7. 
Experience in managing and assessing regulatory and quality systems  

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