US Regulatory Affairs Expert
As part of the Regulatory Affairs Group, Adriana works with a variety of low/ high-risk devices under the EU MDR.
The key expertise areas of Adriana
- Technical Documentation set up and review for Class I-III medical devices, regulatory report writing, gap analyses with remediation for MDR transition, and project coordination and support.
- Interacting with Notified Bodies, resolving potential regulatory issues and negotiating submission issues with agency personnel.
- MDR transition training in topics related to Technical Documentation (Annex I-IV, MDR).
- Reviewing advertising, labeling, promotional items for compliance to MDR.
- Reviewing /performing gap analyses for clinical evaluation reports (CERs) to MEDDEV 2.7/1 Rev. 4 and MDR.
- Performing gap analyses to IVDR for Diagnostics products, updating IVD Technical Documentation to IVDR compliance.
Adriana about working at Qserve
'Working at Qserve has been like working with extended family, who all happen to be industry experts. It is an environment where one is supported and encouraged to ask questions, problem solve and develop oneself as much as possible – those are all qualities that make a great consultant. Ultimately, to be client-focused is to be people-focused; therefore, working at Qserve means bringing empathy on the job, as much as technical skills. I couldn’t imagine a better place to work'.
She worked in Regulatory Affairs at Medtronic and Oasis Medical, gaining valuable experience with Class I-III devices under EU medical device (MDD/AIMDD) regulation, as well as across various emerging markets. Adriana started as a Quality Control Chemist at a multinational biopharmaceutical firm, Grifols Inc., and was a part of their Diagnostic division, which develops diagnostic products in areas such as immunohematology, hemostasis, parasitology, immunology and blood transfusion.
Adriana holds degrees in Biochemistry (BSc) from Seton Hall University and Regulatory Science (MSc) from University of Southern California.
Learn more about our services within Regulatory Affairs