Overall goal of the position:

Advance the company’s quality system by leading projects related to achieving compliance to additional, new or updated regulatory requirements.


What you can expect with us:

  • Monitor the regulatory environment and identify any relevant new or updated QMS requirements
  • Perform gap analyses of the Osypka AG QMS against additional, new or updated regulatory requirements
  • Initiate and lead projects to close identified gaps and achieve compliance to applicable requirements
  • Set up project plans and manage time and resources of regulatory compliance projects
  • Take over and complete key tasks within regulatory compliance projects
  • Help staff members understand requirements within their area of responsibility and assist them in completing assigned tasks
  • Assist in preparation of and accompany audits by regulatory bodies on newly implemented QMS requirements
  • Support general communication with regulatory bodies
  • Provide general assistance to the QM department as needed
  • Review and update existing gap analysis on 21 CFR Part 820 and initiate project to close any remaining gaps
  • Take over key tasks within the project and assist staff members in understanding and completing their assigned tasks
  • Perform mock audit after closure of all tasks
  • Accompany initial FDA audit


What we want from you:

  • Vocational education or University Degree in Engineering or similar relevant field
  • Additional education in quality management and related fields advantageous
  • Minimum of 5 years working experience in the medical devices industry, not necessarily within a QM or RA position but with a deep understanding of all major QMS requirements for medical device manufacturers such as ISO 13485 and 21 CFR Part 820 and hands on experience in their implementation
  • Auditing experience
  • Proficient in both German and English
  • Good writing skills


We offer:

  • We are a professionally managed family business to which values are important
  • As an international medical technology company we distinguish ourselves through our innovative special products
  • We encourage and challenge you
  • We offer a friendly workplace atmosphere, flexible working hours with core time attendance
  • Professional development and qualification opportunities through numerous training courses
  • Company medical examinations


Project Manager Regulatory Compliance (m/f/d)

We look forward to hearing from you and are waiting for your application to this job advertisement!

Please send your application to jobs@osypka.de

or by mail:

Earl-H.-Wood-Strasse 1
79618 Rheinfelden-Herten