10 FDA 510(k) submission experts

Experience: Sr. Director, Regulatory Affairs & Quality Assurance · Pulse Biosciences, Inc.

Former Sr. Director, Regulatory Affairs & Quality Assurance at Pulse Biosciences (2016–2023), with earlier roles as Vice President, Quality Assurance & Regulatory Affairs at VytronUS (2012–2014) and Sr. Director Regulatory Affairs US & EMEA at Solta Medical (2011–2012). An's profile cites 28+ years in the Class II and III medical device industry, including VC-funded start-ups and public companies, and a record of timely domestic FDA 510(k) achievements.

Experience: Regulatory Affairs Manager · Streck

Regulatory Affairs Manager at Streck (2014–2022) and at Cardinal Health (from 2022), and Program Manager Regulatory Affairs at Olympus Corporation since 2025. Deb's profile describes over 20 years in medical device compliance and developing U.S. and international regulatory strategies, including 19 510(k) submissions, one De Novo and pre-submissions, plus oversight of labeling and technical documentation.

Experience: Vice President Clinical and Regulatory Affairs · Endovascular Engineering

Vice President Clinical and Regulatory Affairs at Endovascular Engineering since 2021, with earlier roles as Sr. Director, Clinical & Regulatory Affairs at ShockWave Medical (2013–2015), Director QA RA CA at Arstasis (2010–2013) and Senior Manager Regulatory Affairs at Acclarent (2005–2010). Debra's profile lists FDA regulatory submissions for all classes of medical devices, including 510(k), PMA, HDE and IDE, and communications with FDA and notified bodies.

Experience: Director of Regulatory Affairs · Getinge

Director of Regulatory Affairs at Getinge since 2020, after Senior Manager Regulatory Affairs (2017–2020), Manager Regulatory Affairs (2014–2017) and Regulatory Affairs Program Manager (2010–2014) roles there. Helder's profile describes managing a team of 8 regulatory and 4 labeling professionals and being responsible for the device submissions needed to obtain PMA, 510(k) and international product registrations, including EU MDR certification.

Experience: Regulatory Affairs Manager · E2 - Endovascular Engineering

Regulatory Affairs Manager at E2 - Endovascular Engineering since March 2026, following Senior Regulatory Affairs Specialist at PROCEPT BioRobotics (2021–2026) and Regulatory Affairs Specialist at Medtronic (2018–2021). Ishita's profile lists 510(k) submission and preparation of the 510(k) summary among core competencies, alongside PMA submissions, the De Novo pathway, pre-submission documentation and IDE applications.

Experience: Senior Manager Regulatory Affairs · Heartflow

Senior Manager Regulatory Affairs at Heartflow since October 2024, after Regulatory Affairs Program Manager and Principal Regulatory Affairs Specialist roles at Cleerly (2023–2024) and regulatory roles at BD (2022–2023). Kristen's profile headline cites SaMD AI/ML medical devices and describes Kristen as a 510k Submission Expert with 10+ years in the medical device industry.

Experience: Director Regulatory Affairs · Abbott Rapid Diagnostics

Director RAQACA at Osler Diagnostics since 2023, and formerly Director Regulatory Affairs at Abbott Rapid Diagnostics (2019–2024) and Director, Diagnostics Regulatory Affairs at Haemonetics (2016–2019). Nancy's profile describes 19+ years of regulatory affairs experience in the medical device industry, including IND, IDE, BLA, PMA and 510(k) submissions and interactions and negotiations with FDA.

Experience: Regulatory Affairs Manager · Medtronic

Former Regulatory Affairs Manager at Medtronic (2018–2021), after Senior Regulatory Affairs Specialist (2014–2018) and Regulatory Affairs Specialist (2011–2014) roles there and quality assurance roles at Boston Scientific (2006–2011). In the manager role, Ray's profile describes leading global regulatory strategies for Class III medical devices, ensuring compliance with FDA 510(k)/PMA and EU MDR requirements.

Experience: Sr. Director of Regulatory Affairs · CureMetrix

Sr. Director of Regulatory Affairs at CureMetrix since June 2022, after Director of Regulatory Affairs there (2021–2022), Senior Manager Regulatory Affairs at Vyaire Medical (2019–2021) and regulatory roles at Alma Lasers North America (2018–2019). Rekha's profile cites 13+ years in medical devices and describes leading 510(k) and global regulatory submissions from initiation through approval, including remediation and audits.

Experience: Senior Manager Regulatory Affairs · Seegene USA

Senior Manager Regulatory Affairs at Seegene USA since July 2024, following Senior Manager, Regulatory Affairs at Cue Health (2022–2024) and Manager, Regulatory Affairs at DiaSorin Molecular LLC (1990–2022). Sharon's profile cites over 34 years of IVD experience, including seventeen years in regulatory affairs, with product authorizations and clearances that include one EUA and 15 cleared 510(k)s.