Bryan McMahon

Global Regulatory Lead (GRL) responsible for three marketed Body Contouring assets. I guide a highly matrixed, international team dedicated to maintaining vigilance on global regulatory requirements, ensuring timely submissions, aligning on consistent product claims, and optimizing organizational strategy in concert with our cross-functional partners. • Departmental leader for asset/business strategy, integrated evidence, and product development. • Proposed solutions and advised senior management on regulatory decisions and business risk. • Lead numerous Health Agency interactions, coordinated responses to information requests and formal letters. • Focus on relationship-building and establishing trust with FDA, NBs, Health Canada, and other regulators. • Set team strategic goals and personnel/resourcing needs to align with business strategy and operational needs. • Supported QMS updates in response to final FDA guidance documents (cybersecurity, software, EMC, etc.) • Outlined systems integrations for labeling, RIMS, distribution controls, and metrics. • Established device-specific due-diligence processes and leadership/culture workshops for Aesthetics RA team. • Promoted awareness of regulatory compliance and customer requirements throughout organization. • Oversaw the writing, submission, and coordination of 510(k)s, EU MDR Technical Documentation, Investigational Device Exemptions and international regulatory submissions for electromechanical systems per project timelines

Responsible for advising medical device companies on portfolio strategy, compliance projects, and systems integrations. Following recommendations, I coordinated resourcing, organization, and execution to achieve business goals. • Advised various medical device companies on portfolio strategy, compliance projects, and systems integrations. • Project manager for MDR team, driving for assembly/submission of new MDR applications (1/month). • Biocompatibility SME, negotiating contact material requirements with NBs and gathering supplier CML. • Wrote and provided support for orthopedics 510(k)s, including cement spacers and knee/hip replacements. • Acted as regulatory representative for due diligence and compliance assessments for orthopedic technologies. • Performed audits of technical documentation prior to MDR submission to identify improvement opportunities. • Analyzed regulatory intelligence updates and presented findings/impact to executive teams. • Helped perform review of DMS/CMS project that had fallen significantly behind, introduced new operating mechanisms to re-align and drive for accountability to new timeline; project was then successfully completed ahead of the new schedule.

Spine leadership team member, providing direct recommendations for business strategy and enterprise-critical projects. Program owner for pediatric non-fusion scoliosis device (The Tether) during ZimVie transition for instrument update project, responsible for all functional groups including RA/CA, operations, marketing, and engineering (~50 HC total). • Lead market development (indications + populations) and sales training initiatives for cervical disc (Mobi-C) • Provided reimbursement strategy for CPT code creation, PAP build-out, and society engagement • Oversaw global Spine Clinical Affairs operations across three sites with domestic and international teams • Work stream lead for MDR Clinical Affairs, focused on updating CERs and initiating 20+ PMCF • Supported build-out of mymobility enabling technology platform and evidence plan for Spine • Lead MDR brand reduction activities to streamline portfolio and reduce transitional costs • Protocol finalization, kick-off, and oversight of 10 site, 200 patient registry study supporting HDE approval • Identified critical business needs and developed 5 research projects with HCPs, through publication • Publication strategy for podium/journal activity, including manuscript writing for Mobi-C 10-Year study • Identification and remediation of Clinical Evaluation Report gaps to MEDDEV 2.7/1 REV 4 for Spine portfolio

See above (ZimVie, Clinical Affairs Director)

Departmental leader able to achieve FDA approval for first humanitarian pediatric spine device in 15 years within one 75-day review cycle, structuring and directing teams (RA/CA/DE) to write submission from scratch within 30 days. • Provided strategy for innovative technologies including robotics, navigation, provided guidance for all FDA submissions regarding ROSA One robotic system and achieved clearances after significant AI requests • Managed submissions, promotions, advertising, and annual reporting for US Class III device (Mobi-C) • Managed a team of 9 to support various projects including distribution control system integration and MDR • Oversaw strategy and submission activities for high-priority items within the Spine business unit (US Class II) • Budget planning and management for Regulatory Affairs team (~$2M), focusing on a bottom-up approach • Frequently requested collaborator with Robotics and Craniomaxillofacial business units to provide regulatory counsel and strategy recommendations on business initiatives or development opportunities

Team lead for Engineering Services Regulatory Affairs group focused on specialty and patient-matched devices. Expert knowledge on global custom or patient-specific device pathways, including envelope 510(k)s and additive manufacturing. • Obtained 510(k) clearance and CE marking for pediatric expandable knee device for limb length issues • Managed EU dossier submissions group, providing guidance and review on design dossier submissions for design examination certificate renewals for orthopedic devices (e.g. knees, hips, shoulder, etc.) • Lead for the Regulatory Affairs Development Steering Committee: managing budgeting, interviews, and onboarding for interns as well as creating development sessions/programs for full-time team members • Frequent guest lecturer at Purdue University for engineering students on practical applications of engineering in a regulated space, providing insight on quality system, clinical, and registration requirements • Identified areas for improvement and programmed group tools to automate repetitive tasks

Member of Ryan Gilbert Research Lab, which specializes in novel biomaterials for spinal cord repair. Research included electrospinning, microstamping, SEM, films, cell culture, CAD (Solidworks, AutoCAD), fluorescent microscopy, rheometry, MATLAB, and hydrogels. My focus was on the fabrication of a novel migration assay using electrospun fibers. The invention was submitted for a provisional patent within RPI.

Intern working for Dr. Thomas Devlin, renowned stroke specialist, and Dr. Francis Fesmire, nationally recognized expert on heart attacks. Responsibilities included stroke intervention research, emergency room support, source documentation creation, informed consent, patient enrollment, and data tracking.

Teaching Assistant for the highest general engineering physics course. I conducted lab sessions, reviewed assignments, held office hours, and administered/graded tests.