Regulatory Affairs Specialist

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)