Boston Chapter In Person Event: Navigating Evolving Global Requirements to Strengthen Regulatory Rea

Join leading regulatory affairs professionals for an in-depth discussion on navigating evolving global requirements. This panel features experts from Ketryx Life Cycle Management, LexisNexis Reed Tech, and Dräger, who will share practical insights on streamlining compliance, optimizing regulatory workflows, and preparing for upcoming international changes. Erez Kaminski (Ketryx), CEO and co-founder, brings a technology-driven perspective on modernizing quality and regulatory processes through automation and traceability. Robin Schilling (LexisNexis Reed Tech) leads global regulatory solutions across the life sciences and offers expertise in compliance strategy, operational excellence, and emerging global guidance. John Ferros (Dräger) contributes over 35 years of regulatory experience, including FDA review and extensive work with global submissions under EU MDR, MDSAP, and ISO 13485. Together, the panel will provide actionable guidance to strengthen regulatory readiness worldwide.

Registration Fees & Deadlines

Agenda

5:30 – 6:00pm Welcome reception and networking

6:00 – 6:45pm Panel Discussion on Management of Global Requirements

6:45 – 8:30pm Open networking with light appetizers and drinks

Speakers

Robin Schilling
Head of Regulatory Compliance Services at LexisNexis Reed Tech

Robin Schilling leads a high-performing global team dedicated to delivering tailored regulatory solutions for clients across the life sciences sector. With deep expertise in compliance, quality assurance, and operational excellence, she ensures that services meet the highest industry standards while supporting client needs across regulatory processes for medical devices, medicinal products, and cosmetics.

In her role, she develops and executes operational strategies that optimize regulatory workflows, strengthen quality systems, and improve efficiency, enabling clients to stay ahead of evolving global regulatory requirements. She actively contributes to regulatory thought leadership by monitoring emerging global requirements—including evolving guidance from Health Canada and advancements related to FHIR—while representing the organization at industry forums and supporting educational initiatives across the regulatory community.

Robin holds a Bachelor of Arts and a Master of Arts from Johns Hopkins University, as well as an MBA from SBS Swiss Business School. Through her commitment to excellence and innovation, she advances the evolution of regulatory compliance services and helps position the organization as a trusted partner for global regulatory success.

John Ferros
Director of Regulatory Affairs, Drager

With over 35 years of experience in various roles within Regulatory Affairs and Compliance, Mr. Ferros began his career at the FDA while working as a scientific reviewer, as well as CDRH's QA compliance team.  He has authored 510(k)s, PMAs, IDEs, and IND submissions in various disciplines including prosthetic mechanical heart valves, orthopedic implants, human tissue implants, Class 3 adhesives, and biological injectables.  He has also worked with HCTPs (Human Cells, Tissues, and Cellular and Tissue-based Products) as the regulation by FDA for these products continue to evolve.  Mr. Ferros has been the Management Representative/Person Responsible for Regulatory Compliance for EU regulatory requirements under MDSAP, EU MDR, and ISO 13485.  Mr. Ferros holds a Bachelor's Degree in Mechanical Engineering from the University of Florida. 

Sponsors

Ketryx

Lexisnexis Reed Tech

Hays

Location

Ketryx
1 Main St
floor 5
Cambridge, MA 02142

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions