Regulatory Compliance Specialist

1 day ago


Sundsvall, Sweden TN Sweden Full time

TN Sweden is committed to cultivating an inclusive environment that enhances accessibility, participation, and the development of world-class mobility solutions. We are seeking a Site Quality Manager to join our team and contribute to our mission.

Job Description:

As a Site Quality Manager, you will be responsible for leading the site QA team and ensuring compliance with regulatory requirements. You will develop and manage the local QA team, support the organization to continuously improve quality, and ensure the implementation and efficiency of QMS processes within the organization.

Responsibilities:

  • Lead site Quality Team
  • PRRC (where the site is the legal manufacturer)
  • QA support for site functions including Operation, Production, Supply Chain, R&D
  • Ensure assigned QMS processes are compliant with applicable regulatory requirements for medical devices
  • Review the implementation and efficiency of QMS processes within the organization
  • Function as process responsible / process owner for assigned QMS processes
  • Support quality reporting, KPI collection and assessment
  • Host and coordinate audits/inspections
  • Act as internal auditor

Requirements:

  • Master's degree or Bachelor's degree preferably in science and engineering
  • Good knowledge of quality systems, quality assurance, and regulatory standards within the Medical Device or Pharma industry
  • At least 5 years of working experience in a similar role
  • Able to be PRRC for products where the site is the legal manufacturer
  • Previous experience ensuring QMS processes are compliant with applicable regulatory requirements for medical devices
  • Good knowledge of risk management
  • Fluent in English and Swedish both oral and written


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