RA Specialist

My client is a Medtech Company based in the Eindhoven region, that is in need of support from a skilled RA Specialist for their clinical study submission to FDA. Initial contract is 4 months (high chance of extension); with only 1 day per week on-site requirement. 

Interview + offer will happen next week (via teams), so get in touch ASAP if interested.   

Role:

• Support clinical study submission to FDA for Class III active implantable devices
• Create instructions of use and requirements, write packaging plans,  create labels, prepare IFU, maintain applicable standard use.
• Utilize existing documentation for update according to current regulations
• On vs off site: flexible; can be on-site 1 day each week

Skills:

• Must have strong MDR knowledge and FDA expertise
• Knowledge of standards requirements for Labelling (ISO 15223, 20417)
• +5 years experience in the Medtech sector withing RA domains (ISO13485 understanding)
• Nice to have experience with RA technical documentation
• Languages: English  

Send CV and phone number to c.girdwood@panda-int.com to discuss further.