Technical Writer - CER Specialist

Naples, Florida (US)
07 Jan 2021
06 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Our client is a Global Medical Device Company based in Naples, FL.


They are looking to add a CER technical writer to their regulatory writing team. This role is a brand new position due to growth within the business. 


You will be joining an established team working onsite in their amazing facility based in Florida. 


Alongside working with the team and exciting new devices there are also some incredible and unique benefits: 


- On site Gym 


- They have their own hotel


- on site chef! - Free lunches cooked for you everyday.


Education and Experience:

  • Master’s degree required, preferably with a scientific emphasis.
  • PhD preferred or 5 years of documented scientific/research experience.
  • 2 years’ experience in clinical evaluation report writing (CER) in the medical device industry is required.
  • Strong knowledge of orthopedic medical and surgical terminology
  • Experience writing study protocols and final study reports

Knowledge and Skill Requirements/Specialized Courses and Training:

  • Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)
  • Working knowledge of MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745
  • Working knowledge of ISO 14155.
  • Working knowledge of biomedical databases (i.e., Pubmed, Embase)
  • A thorough understanding of the National Library of Medicine’s Medical Subject Headings (MeSH)
  • Proficient in document development and management software skills: Word/ Excel/ PowerPoint.

If you are interested in working with a fantastic company and taking your career to the next step please apply now!

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