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.
• 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.
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Discover why candidates choose a career at Abbott Switzerland.
JOB FAMILY:Operations Quality
DIVISION:EPD Established Pharma
LOCATION:Switzerland > Basel : H-127 Lobby
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable