US Consultant Regulatory Affairs
Adriana Becker, MSc
Regulatory Affairs Consultant
As part of the Regulatory Affairs
group, Adriana is an expert in different class devices for the US and EU Medical Device Regulations.
Adriana has been involved in regulatory compliance projects for several types of devices.
Before joining Qserve, she worked as a Regulatory Affairs Specialist at Medtronic Diabetes. Medtronic Diabetes specializes in insulin pumps and glucose monitoring. In this job, Adriana has gained valuable experience with the whole range of regulatory work for different class devices including class III under both US and EU medical device regulation as well as for other global regulations.
Her scope of work included writing on submissions, regulatory strategies, interaction with regulatory authorities, approval of labeling and advertising, maintaining approvals and licenses, provide regulatory support for European clinical trials and participating in Notified Body audits (LNE/G-MED) among others.
Adriana started her career as a Quality Control Chemist at a biopharmaceutical firm Grifols Biologics Inc. Grifols is a multinational, where Adriana was part of their Diagnostic division that develops diagnostic products in the areas of immunohematology, hemostasis, immunology and blood transfusion.
From there she moved to medical devices, working at Oasis Medical, Inc. as a Regulatory Affairs Specialist. In that role, she had the opportunity to gain experience with the broader area of regulatory affairs, such as submissions to FDA but also a lot of international regulators, adverse event reporting, maintaining technical documentation under the MDD, maintaining registrations, and assistance in audits and inspections.
Adriana has a Bachelor's degree in Biochemistry and a Master's degree in Regulatory Science.
Learn more about our services within Regulatory Affairs