Senior RA specialist

Posted 18 June 2024
LocationUnited States of America
Job type Permanent
Discipline Regulatory
Contact NameMichael Kakoullis

Job description

At BioTalent, we are working with a client exclusively to fill their Senior RA Specialist position. They are a world leading Device company focused on developing new products. They are currently looking to both bring new products to market and introduce existing pipeline into new markets!


You will be a key member of an established team making an impact in a crucial area of the device world


This role will offer you

  • To work in a fast-paced environment and the ability to take a huge impact.
  • To work across global markets for new product introduction and new product development
  • High visibility from the senior leadership team including working directly with senior stakeholders


You will be responsible for

  • For leading new product introduction into the US, Canada and ROW markets
  • Leading MDR transitions
  • Labelling and UDI writing
  • Post marketing activities


You will bring the following

  • Hands on Regulatory experience within Device  in an ISO13485 environment
  • Worked on MDR transitions
  • Hands on 510k writing OR post marketing activities for FDA
  • Ideal candidates would have to MDSAP regions
  • BSc or MSc in a relevant Life Sciences subject


If you want to be part of an innovative thinking, growing company where you can grow and expand your current knowledge, GET IN TOUCH - Please email me at or on 857-391-6433 if you think you could be a good match.