Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Regulatory Affairs Specialist

Posted Nov 3, 2022
Job ID: JJJP00013091
Location
Zuchwil
Hours/week
40 hrs/week
Timeline
1 year , 1 month
Starts: Dec 1, 2022
Ends: Dec 31, 2023
Payrate range
Unknown
Application Deadline: Dec 1, 2022 12:00 PM

MDR RA 

Sr. Regulatory Affairs Specialist (onsite)

Job Description: 


Support local franchise Regulatory team for various execution activities in conjunction with base business support. 
 

  • Perform Labeling and Promotional Material Reviews as assigned.
  • Perform Regulatory Change assessments as assigned.
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File and Design Dossier documentation as instructed and assigned.
  • Provide regulatory support for Life Cycle Management Projects as assigned 
  • Provide regulatory support for New Project Development projects with focus on CE marking and US requirements if assigned

    What we need from the candidates: 

 

  • At least 4 years of experience in Medical Device Industry and Regulatory Affairs. 
  • Understanding of MDR requirements regarding required content of Technical Documentation  (focus on ANNEX IX of Regulation (EU) 2017/745) 
  • Understanding of requirements of Council Directive 93/42/EEC (MDD)
  • Previous experience within Regulatory Affairs at DePuy Synthes preferred
  • Experience with creation and maintenance of EU Design Dossiers and Technical Documentation in PLM Systems preferred
  • Experience in IT system documentation and database management preferred
  • Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
  • Ability to comprehend principles of engineering, physiology, and medical device use.
  • Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset. 

    NB: the position foresees presence at site according to JNJ flex rule (3 days physical presence in the office, 2 days home office)

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