2023-08-23 14:48:55
2023-02-22 15:26:08

Quality Assurance and Regulatory Affairs (QA/RA) manager

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Job Description

  • Ensure that the Quality Management System requirements are effectively established and in accordance with applicable medical device regulations for FORANS  related activities.
  • Support customers by providing   the technical files and related documentation.
  • Conduct internal audits and provide guidance regarding best practices and continuous improvement.
  • Support core quality systems including root cause analysis, CAPA, non conformance, chance control, and risk management, as well as control of documentation and records.
  • Coordinate external audits from notified bodies and customers. Follow up on any actions resulting from these audits.
  • Maintain expert current knowledge of European and foreign regulations, legislations, best practices and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies.
  • Manage key quality and regulatory affairs initiatives to drive continuous improvement.
  • Other duties as assigned.

Requirements

  • A Master’s or a Bachelor’s degree are considered as plus.
  • An experience in a quality assurance and/or regulatory affairs role. Prefereble in a Medical Device field.
  • Understanding of a Quality Management System, and requirements for ISO 13485, MDR and other relevant regulations.
  • Understanding of quality assurance concepts and practices.
  • Ability to interpret and apply regulations and compliance concepts.
  • Experience in regulatory submissions, registrations and other product approval documentation is advantage.
  • Excellent communication skills, written and verbal. Fluent written and spoken English, Estonian, additional Russian languages are considered a plus.
  • Computer literate (MS Office)
  • Strong organisational and presentation skills, as well as the ability to multi-task and work well under pressure.
  • Detail oriented, team player.

Company offers

  • You will be joining a team of enthusiastic and passionate colleagues.
  • FORANS is a fast growing company, so you can grow with us and grow in your area of expertise or interest.
  • You will be able to work in office or home office.
  • You will get an attractive salary package and instruments for work.