67 days ago on jobs.kellyservices.ch

Senior Regulatory Affairs Specialist

Kelly Services (Schweiz) AG

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Senior Regulatory Affairs Specialist

Kelly Scientific Resources is a competent and experienced partner of the life science industry. 
 
Our client is an international medical device company focused on orthopedics. For the site in the greater Zurich area we are looking for a reliable and motivated person for the position
 
 
Senior Regulatory Affairs Specialist
 
 
Key responsibilities

  • Responsible for developing regulatory submission strategies, registration dossiers and managing departmental projects; supervising the creation and review of labeling; providing guidance and consultation for EU, US and international regulations
  • File submissions to national and international authorities
  • Interacting with regulatory agencies, and certification bodies
  • Advise product development teams when developing new products to define regulatory requirements for Europe and international markets
  • Prepare the technical documentation for the conformity assessment of products
  • Support of Post Market Surveillance activities; maintain and update the technical documentation
  • Perform conformity assessment of custom made devices according to the applicable regulations
  • Support of external audits (authorities, notified body)
  • Create and hold training in relation to regulatory topics

 
 
Required qualifications and core competencies

  • Degree in Medicine, Science or Engineering
  • Minimum 3 years working experience in Regulatory Affairs in medical device industry and experienced in applying EU & US medical device regulations and guidance documents
  • Ideally experience in RA in orthopedics
  • Sound and comprehensive communication and diplomacy
  • Very accurate way of working and outstanding organizational skills
  • Strong written and verbal communication skills including presentation skills
  • You are fluent in English and have basic German knowledge
  • Excellent MS Office skills

 
  
Ms.Tanja Güntert, PhD, Tel. +41 (0)44 225 41 07, will be happy to answer your questions regarding the position and our client.
 
 
 
Kelly Services (Schweiz) AG, Kelly Scientific Resources, Löwenstrasse 29, 8001 Zürich, 
Öffnungszeiten von Mo - Fr 8h00 – 12h00 / 13h30 – 18h00