The AKKA Technologies Group (12'000 employees, 1.2b EUR turnover) is a leading technical consultancy group, developing its AKKA LifeSciences brand through Europe.
On behalf of one of our best clients, a leading medical device manufacturer we are currently seeking a Senior Engineer specialized in Regulatory Reporting to join their international team on a permanent basis as soon as possible.
You will be part of the regulatory reporting Group within the Compliant Handling Department of the Quality & Regulatory Affairs organization interacting with different groups and departments around the globe. The scope will be to ensure efficient and compliant processes in line with corporate processes, standards and applicable international legislation/regulations.
Main tasks: • Preform reportability assessments and run decision trees, create and send incident reports, Periodic Summary Reports and prepare similar Incidents lists for submission to FDA and/or Competent Authorities. • Prepare and answer queries from other departments concerning reportable complaints, create data for statistical analyses, management reviews, quality trendings and prepare product related data summaries. • Help to improve existing processes, forms, tools and databases. • Answer case specific or general requests from Competent Authorities and act as representative of the Regulatory Reporting team. • Support updates and changes of internal procedures and create internal guidelines and forms. • Train and guide new employees within Regulatory Reporting team and support approving regulatory reports to FDA and/or Competent Authorities (as agreed with Regulator Reporting Team Leader).
• Bachelor in natural sciences (or other area) or engineering degree • Significant (3-5 years) work experience in related industry (e.g. medical devices, pharma, biotech or health management) in relevant areas of Quality Management, Regulatory Affairs or management of product compliance. • Strong regulatory background knowledge in medical device industry and good problem solving abilities • Know-how in writing reports and developing metrics • Excellent command of English and German both verbal and written
If this sound like your next challenge please send me your updated CV to email@example.com or call me for more details on +41 58 717 7044.