Job Description for Manager Corporate Affairs by wun13775

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									                                         Job Description

Position Title:                                                  Reports To
Manager, Quality Systems / Regulatory Affairs                    Vice President / General Manager
Date Reviewed                                                    Department
3/28/2005                                                        Quality Systems / Regulatory Affairs
Salary Grade: 28


General Purpose

   •   Assume a leadership role with authority for the development, implementation, evaluation, and
       maintenance of a comprehensive and effective quality and regulatory program that complies
       with FDA regulations, ISO requirements, Corporate Regulatory Compliance and other
       applicable regulatory bodies or standards.
   •   Responsible for all aspects of coaching, mentoring, managing and supervising the activities and
       personnel of the Quality Assurance/Regulatory Affairs Department.


Essential Functions

  General:
   •   Responsible for directly supervising the quality assurance personnel. This includes training;
       assigning, prioritizing and monitoring work duties; and providing performance and
       compensation reviews.
   •   Directly and frequently communicates and interacts with all departments including
       manufacturing, R&D and sales/marketing and other Dentsply Divisions, including Friadent
       Germany and Dentsply Corporate Compliance with regards to quality or regulatory issues.
   •   Develops and manages departmental budget and Departmental resources.
   •   Directly and frequently communicates and interacts with other DENTSPLY sister divisions.
   •   Plan future needs and accommodate expansion of the Quality Assurance Department.
   •   Provide reports to the president and management staff on the status of quality programs and
       operations.
   •   Leads the management staff in addressing quality issues.
   •   Acts as management representative for Regulatory bodies.
   •   Perform other duties at the direction of the General Manager.

  Quality Assurance:
   •   Direct and when necessary, perform inspections of raw materials, in-process materials, labeling
       and finished goods.
   •   Direct and when necessary, perform analytical quality control tests and interpret the results
       (i.e., x-ray diffraction)
   •   Direct and when necessary, perform internal audits of processes, facilities and documentation to
       assure compliance with internal procedures and FDA/ISO regulations and requirements.
   •   Direct and when necessary, perform audits of component vendors and contract manufacturers
       and service suppliers to assure quality materials and services are provided that meet Friadent
       CeraMed’s requirements.


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   •   Perform and evaluate sterilization validations (EtO, Gamma) according to published standard
       methods, as well as playing a key role in all other validation efforts.
   •   Oversee the documentation and evaluation of customer complaints, and direct corrective
       actions as necessary, as well as reporting serious complaint and MDR information to the
       Corporate Complaint Officer.
   •   Oversees and assures the smooth operation of the CAPA System.

  Documentation:
   •  Write and implement procedures and specifications detailing every aspect of an effective
      quality system that complies with FDA, ISO, Corporate Regulatory Compliance and other
      applicable regulations and requirements.
   • Maintain and control all documentation involved in the quality system (i.e., Device Master
      Records, Device History Records, CAPA system records, complaint system records, etc.).
      Oversee Document Control.
  Regulatory:
   •   Responsible for assisting with the review of Consultant(s) prepared IDE’s, 510(k)’s, PMA’s,
       etc. and assuring the submissions are submitted and tracked with the FDA or other regulatory
       bodies on a timely basis.
   •   Oversees FDA inspections, ISO Assessments and customer audits.
   •   Acts as liaison between CeraMed, the FDA, and other regulatory bodies with regards to quality
       or regulatory issues.


Job Qualifications
Knowledge, Skills & Abilities
   •   Minimum of 5 years experience with FDA Class III devices, including experience with FDA
       inspections and responses
   •   Proven Leadership ability and 10 years experience managing direct reports
   •   10 years experience within a manufacturing environment with direct quality system working
       knowledge.
   •   10 years budget preparation/administration experience.
   •   Ability to read and write English Language
   •   Strong decision-making skills
   •   Excellent communication skills – both written and oral
   •   Ability to multi-task
   •   Ability to work as a team player
   •   Ability to follow written guidelines
   •   Mathematical ability
   •   Ability to work independently, plan and prioritize
   •   Ability to be flexible/adapt as daily schedule may change rapidly
   •   Computer proficiency with standard software programs




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Education Or Formal Training
   •   Bachelors Degree in science based or other appropriate curriculum
   •   3-5 years extensive and applicable experience in a regulated medical products or equivalent
       company.
   •   Training in FDA and ISO Quality System regulations and standards and associated documents
       such as Risk Management.


Material And Equipment Directly Used
   •   Various analytical instruments
   •   Personal computer, copier, printer.
   •   Telephone, Fax


Note: This job description is not intended to be an exhaustive list of all duties,
      responsibilities, or qualifications associated with the job.


Department Manager Approval:                                           Date:


Human Resources Approval:                                              Date:



Employee signature below signifies understanding and agreement with the requirements and
responsibilities outlined in this job description.


Signature:_____________________________________________               Date:___________________




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