Mittwoch, 22 Januar 2020

Clinical and Regulatory Affairs Specialist (m/f, 100%)

We are CAScination AG, a fast-growing and award-winning medical device manufacturer. We are dedicated to development, manufacturing and commercialization of innovative robotic and image-guided solutions for surgical and interventional medical procedures. Our products enable physicians to perform reproducible and standardized medical treatments, providing patients with minimally-invasive, yet effective treatments. To strengthen our Clinical and Regulatory Affairs Team, CAScination is looking for a:

Clinical and Regulatory Affairs Specialist (m/f, 100%)

In this position, you will support regulatory submissions and key processes of medical device lifecycle management, such as post-market surveillance, risk management and clinical evaluation.

RESPONSIBILITIES

  • Create and update technical files and support the transition from MDD to MDR
  • Liaise with notified bodies, competent authorities and regulatory agencies and support global regulatory submissions
  • Support the further development and maintenance of relevant processes within CAScination’s quality management system to comply with global regulatory requirements Support internal audits and Health Authority inspections
  • Perform systematic literature reviews and data base searches and create related document
  • Critically assess and evaluate clinical data related to CAScination’s products and the clinical state of the art
  • Collect, analyse and evaluate post-market surveillance data and ensure information exchange between stakeholders

PROFILE

  • Degree in life science and at least 3 years of relevant work experience in the medical device industry
  • Good understanding of the regulatory framework of medical device registrations in the EU and US and the legal and normative landscape (e.g., MDR (EU) 2017/745, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366, ISO 10993)
  • Proficient in systematic literature searches and data base searches using PubMed or Embase
  • Experience in performing clinical evaluation of medical devices (class IIa or higher) conform with MEDDEV 2.7/1 Rev.4
  • Proactive, organised, structured and meticulous way of working
  • Very good command of written and spoken English

We offer a dynamic team and an exciting, fast-paced and international work environment in the medical device industry. Are you curious, highly motivated and flexible? Do you think you have what it takes?
Then send us your application* (CV, Motivation Letter, Working References, Diploma, etc.).
CONTACT JOBS@CASCINATION.COM, Phone: Stefan Aebischer +41 31 552 04 30


* Applications from recruitment agencies will not be considered

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