Seamus Moore

Since 2006 I have been working for small, mid-sized and multinational medical device companies in Quality and Regulatory Affairs. I gained experience in various fields of medical devices. This includes the following types of products,  Class III Cardiovascular Stents and Ballons, Brachytherapy Class IIb & Class IIa, Dental equipment Class IIa to Class I including Custom Made Devices and Software as a medical device.

I am an experienced RA and QA manager with a Master’s Degree In EU Regulatory Affairs, through Krems Medical University in Vienna. I have experience in the usual medical device standards QMS (ISO 13485) risk management (ISO 14971), software (IEC 62304), usability (ISO 62344), Management Review and auditing. Additionally, I am Regulatory Affairs Submission Specialist for product registration and market access Worldwide and experienced  in the review, drafting and application of templates and/or procedures, work instructions for quality management (ISO 13485).

I hold two awards in the field of Regulatory affairs, in 2021 I won the Elemed MEDTECH Team Leader award and in 2022, I won the TOPRA International Award in Communication.

I am proud to be part of such a knowledgeable and professional team of experts as Starodub, where we strive to provide our customers with all their Regulatory and Quality needs in a timely and efficient manner.