QA/RA Specialist 4/ Supervisor

55415, Minneapolis
Feb 28, 2018
Required Education
Bachelors Degree
Position Type
Full time

Position Summary

This position is responsible for supervising a team of quality and regulatory professionals. The candidate will provide quality/regulatory guidance for the Diagnostics Division. Responsibilities include preparing and filing regulatory submissions to support R&D Systems’ products [510(k)s, Technical Files, and international regulatory documents], serve as primary contact for quality/regulatory issues related to assigned products. Experience with In Vitro Diagnostics, Controlled Manufacturing and Aseptic Processing a plus.


Essential Function

  1. Participate in Diagnostics Division (DD) team meetings as Quality/Regulatory representative, and serve as primary contact for quality/regulatory issues in the DD.
  2. Support implementation of quality objectives and plans to assist in maintaining the Quality Management Systems in the DD.
  3. Provide quality/regulatory guidance in the qualification and operation of the controlled manufacturing area in the DD.
  4. File appropriate documentation with regulatory agencies for R&D Systems’ DD products, including 510(k)s, technical files, and license applications.
  5. Respond to customer and supplier quality / regulatory requests regarding R&D Systems’ DD products.
  6. Participate in external audits by regulatory authorities, notified body, and customers.
  7. Work collaboratively with all functions to ensure conformance with all quality and regulatory requirements.
  8. Provide leadership in the DD to ensure compliance with internal and external quality requirements through policy and procedure development and implementation.
  9. Perform additional duties as assigned.


Education and Experience

This position requires a minimum of a Bachelor’s degree with 8 years of experience or Master’s degree with 4 - 6 years of experience in an FDA-regulated industry.


Knowledge, Skills and Abilities

  1. Expert knowledge of Quality Management Systems, including ISO 9001 and ISO 13485.
  2. Knowledge of regulatory requirements in global markets, including US, Canada, and EU.
  3. Excellent verbal and written communication skills including technical writing skills.
  4. Ability to provide organizational leadership by establishing, articulating and modeling the vision and goals; ability to guide others in a direction that aligns with same vision and goal.
  5. Ability to negotiate by collaborating with others to arrive at a conclusion using compromise, persuasion, rational, and diplomacy
  6. Skills in problem solving and critical thinking, including the ability to identify and appropriately evaluate an alternative course of action.
  7. Skills in planning, organizational, time management and multi-tasking.
  8. Ability to make effective decisions and execute an appropriate course of action which complies with quality and regulatory requirements while supporting business objectives.
  9. Knowledge of safety and company rules and policies.
  10. Ability to handle sensitive and proprietary information with discretion and confidentiality.