Spinal USA, LLC is a young and dynamic company with the goal of delivering significant advancements for the treatment of spinal conditions to physicians and patients globally.  The Company is seeking motivated individuals who possess an entrepreneurial spirit, unparalleled integrity and the desire to make a difference.  If you feel these characteristics apply to you, please feel free to contact us regarding the available openings below.

Send Resume & Salary Requirements to:  resumes@spinalusa.com or fax to 601-500-5785

Regulatory Manager

Department(s) Regulatory
Reports to Senior Director of Quality and Regulatory

The Regulatory Manager will provide a depth of knowledge in the areas of medical device regulatory systems (FDA, ISO, MDD and international) to personnel in all areas of the company.  This person will have a strong working knowledge of spinal implant systems and instruments and how they relate to the regulatory requirements.

Summary of essential job functions

• Interpret US and international quality standards into company operating procedures
  
• Ensure that document control records required for international file are established and maintained
  
• Manage DMRs
  
• Ensure product labeling is in accordance to FDA and international filings, such as intended use and labeling standards
  
• Manage training to QSR and ISO regulations to employees
  
• Assist in review and analysis of customer complaint system, MDR and other international required reporting
  
• Plan, schedule and complete projects in a timely manner
  
• Participate in FDA and ISO audits
  • Participate in product teams with regard to implementation of regulatory requirements
  • Responsible for coordination & preparation of regulatory submissions and strategies
  • Develop & maintain regulatory knowledge of European regulations
  • Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
  • Defend company business interest in international standardization groups
  • Update licensing and collect information on registration instructions and regulations
    

Minimum requirements

• BS degree preferably in engineering, sciences or equivalent
  
• Experience working within a ISO 13485, FDA 21 CFR Parts 820 and MDD
  
• Experience in development of technical files for CE Mark
• Experience with interface with FDA, Notified Bodies and other foreign country representatives
• Have written traditional and special 510(k)s

Abilities required

• Strong verbal and written communication skills
  
• Competent in MS Word, Excel.  Competent in MS Project and Visio a plus
  
• Strong knowledge of implant systems in particular to spine
  
• Strong working knowledge of the FDA QSR
• Strong working knowledge in acquiring CE Mark
  
• Must have translate international requirements for filing product into various countries
• Must develop technical files and dossiers
• Must work with product development to establish regulatory paths to product launch
  

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.