Senior Regulatory Specialist

At BioTalent, we are working with a client exclusively to fill their Senior RA Specialist position. They are a world leading IVD 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 IVDR transitions
• Labelling and UDI writing
• Post marketing activities

You will bring the following

• Hands on Regulatory experience within IVDs in an ISO13485 environment
• Worked on IVDR 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 michael.kakoullis@biotalent.com or on 857-391-6433 if you think you could be a good match.