Mark Mortellaro
Sr Principal Regulatory Scientist @Senseonics, Incorporated
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WORK HISTORY
Sr Principal Regulatory Scientist @Senseonics, Incorporated
Germantown, MD, US
Lead and support submissions to US and EU regulatory agencies for Class II and Class diagnostic medical device systems and Class I and Class II 510(k) exempt software applications (web-based and mobile apps). Determine appropriate quality activities and regulatory paths for new products in development and for changes to marketed products. Perform regulatory intelligence and support company compliance with regulations and laws. Regulatory Accomplishments:• US Marketing Applications – Authored and coauthored successful FDA marketing applications including multiple PMA supplements and 30-day notices, the company’s first 510(k) submission, and the company’s first De Novo submission. • EU Marketing Applications – Led the “from scratch” cross-functional marketing application submission that resulted in CE Mark approval under the EU MDR (2017/745); led submission of AIMDD CE certificate renewal; authored numerous successful certificate amendment submissions.• Regulatory Compliance – Authored annual reports for PMA, IDEs, Post-approval Studies (PAS); maintained compliance with FDA UDI database (GUDID), annual registration, and small business designations requirements.• Regulator Issue Resolution – Subject matter expert at in-person and remote meetings with FDA (CDRH and CDER) and Notified Body reviewers that led to resolution of submission issues.• Clinical Trial Submissions – Authored and coauthored successful IDE applications and supplements and successful EU medical device clinical trial applications.Quality Assurance Responsibilities:• Product Development – Evaluate proposed process, product, and QMS changes and advise on appropriate quality assurance activities and regulatory strategy.• Audit Support – Member of team that reviews and updates documentation in advance of Notified Body audits and serves as “backroom” support during audits. • Nonconformities – Member CAPA Review Board and Material Review Board (MRB).
EDUCATION
Youngstown State University
Bachelor of Science (B.S.)
The Ohio State University
Ph.D.
ABOUT MARK MORTELLARO
Former technical Director that gradually and successfully transitioned into a Regulatory Affairs professional. Demonstrated record of bringing medical device hardware/software systems through design and development, manufacturing, clinical testing, regulatory approval (FDA and EU), and product launch through a collaborative and hand-on team leadership approach.• Seven (7) years direct medical device regulatory experience supported by three (3) years in a hybrid regulatory/technical role and 12 years in R&D leadership roles.• Led multiple FDA (510k, PMA, De Novo) and EU MDR submissions that resulted in approval / clearance of Class and Class II medical device systems comprising hardware, firmware, surgical tools, mobile apps, and web-based data management systems for professionals and patients.• Cradle-to-grave PMA submission experience (original PMA submission, supplements, 30-day notices, post-market including PAS, product sunsetting) for hardware/software medical device systems.• IDE and EU CTA submission experience. • In-person and remote interactions with FDA (CDRH and CDER) and notified bodies.• Department and team leadership experience.• Practical knowledge of 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, ISO 14155, IEC 62304, IEC 62366-1, IEC 60601-1, ISO 10993 series, EN 45502-1, ISO 14708-1, as well as related FDA, MDCG, CLSI, and ICH guidance documents.• ISO 13485:2016 Certified Lead Auditor
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