Profile

Congrats to the first group of RCC recipients! Hoping that you can share your experience and recommendation on how to best prepare as i've found the RAPS packet a bit lacking (no offense RAPS). Thanks in advance ------------------------------ Tina O'Brien RAC, MS Director of Global Regulatory Affairs ...

Thanks for that Joy - this fee was not included in the quote from our NB, hence trying to understand if the CECP itself charges a fee and if that fee is payable directly by the applicant or as a pass-through from the NB.  My goal is to gain intelligence to assist with budget planning.   Tina ----- ...

Hi everyone, This message goes out to anyone who's had their CER submitted for CECP review for the MDR application.  I'm trying to glean how much additional cost this incurs and if the review time defined in the Regulation is representative of how long it actually takes?   Thanks in advance for sharing ...

Seeking a Regulatory team member with life sciences education and 1-3 years with a medical device company to join my team to participate in new product development, manage global submissions, and opportunity to get involved with loads of other exciting projects on the horizon in our rapidly growing company.  ...

Thanks for the update Erik any idea when we might expect passage of that new implementing act to allow more time for those with expired MDD certificates? Tina Tina O'Brien MS, RAC Director, Regulatory Affairs p: +64 09 8693035, ext. 214 | e: tina.obrien@aroabio.com corporate: ...