Manager Quality Assurance Medical Device / Person Responsible for Regulatory Compliance
Abbott
Basel, Switzerland
vor 2 Tg.

Abbott Established Pharmaceutical Division (EPD) is looking for a

Manager Quality Assurance Medical Device /

Person Responsible for Regulatory Compliance

The function will fulfill duties of the Person Responsible for Regulatory Compliance for all Quality related activities according to MDR (2017 / 745), Article 15.

Core Job Responsibilities

  • Assure device conformity by performing appropriate checks in accordance with quality management system requirements pertaining to medical device prior to release.
  • Perform formal device release.

  • Verify conformity and maintain technical documentation related to the medical device including Medical Device File, Design and Development File and Risk Management File.
  • Meet post-market surveillance obligations in accordance with Article 10(10).
  • Fulfil reporting obligations referred to in Articles 87 to 91.
  • In the case of investigational devices, issue the statement referred to in Section 4.1 of Chapter II of Annex XV.
  • Support maintenance of ISO 13485 Quality Management System.
  • Provide expert knowledge of Global Regulations and Guidance’s, Corporate and Division Standards to support strategic decision making.
  • Change management oversight assuring appropriate assessment and implementation of device changes.
  • Support the management of quality complaints within the TPM / internal supplier network.
  • Provide support to TPM / Supplier QA in Supplier Management.
  • Effective participation and communication in Device Management Reviews.
  • Promote innovation and continuous improvement to support medical device business.
  • Qualifications

  • Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other relevant scientific discipline. Master’s Degree desired.
  • With relevant science degree : at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
  • Without relevant science degree : at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Extensive knowledge of international and local quality system and compliance legislations and standards.
  • Experience in product lifecycle of a medical device including design and development control phase
  • High level of technical expertise with strong troubleshooting and problem-solving capabilities.
  • Project management and change management expertise with capability to identify and manage resource requirements.
  • Excellent communication skills with ability to communicate effectively both orally and in writing to both internal and external audience.
  • Excellent communication, motivational and interpersonal skills with a teamwork mindset.
  • Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf .

    If you want to upload several documents, don t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)

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