Osstell is looking for a Medtech Quality assurance / Regulatory affairs manager

The dental implant market is one of the worlds’ fastest growing markets, which also drives the need for better diagnostics. Osstell develops and sells diagnostic tools to clinicians world-wide. The Osstell products are approved in most markets, and the Quality System is certified according to ISO 13485.

Osstell was founded in 1999 and is a subsidiary of Biolin Scientific AB. Biolin Scientific is owned by Ratos AB, listed in Stockholm. Osstell has 14 people employed; 11 in Gothenburg and 3 in the US.

Osstell is in an intense development phase and as our QA&RA manager has decided to leave the company, we are now looking for her replacement.

Your main tasks will be to

• Maintain and optimize our quality system according to ISO 13485 and ISO 9001
• Host and manage external and internal quality audits.
• Manage all quality and regulatory relationships with notified bodies, suppliers and customers.
• Manage and be responsible for the Corrective and Preventive Action System (CAPA) and the Issue Handling System, including adverse events reporting.
  
• Manage the Technical File and Risk Management File.
  
• Prepare appropriate documentation for CE mark certification and for other product registrations worldwide.
  
• Initiate, review and approve quality documents and technical reports
  
• Prepare complaint statistics and reports for the Management Reviews
  
• Prepare and lead the Management Reviews

Other tasks are

Manage supplier audits

• Maintain the company’s instrument calibrations
  
• Ensure that product labeling is in compliance with product claims
  
• To attend and participate in risk management activities, especially the risk management process
  
• Participate in R&D meetings
  
• Participate in some development activities, including running Change Order matters.
  
• Support the sales team and R&D in regulatory issues
  
• Review and approve quality documents and technical reports

You probably have a Master of Science in engineering or similar, with experience from similar positions in the Medtech industry. Other qualifications:

• Good knowledge and experience of applying ISO 13485 and ISO 9001.
  
• Good knowledge and experience of FDA regulations and the 510-k process.
  
• Knowledge of and experience from the development of at least Class IIa medical devices, including application of EN 60601 and UL 2601.
  
• Knowledge about CMDCAS, KFDA, SFDA, MHLW, TFDA and Anvisa is an advantage.
  

Good communication skills in English are necessary.

The position is based in Gothenburg, and could include some traveling, mainly to make supplier audits.

If you are interested or have any questions about this position, please contact Anders Petersson:
anders.petersson@osstell.com or +46 31 340 8251