We specialize in navigating the complex regulatory landscape for the Pharma, Combination Products, MedTech, and Medical Device sectors. With over 25 years of experience, we provide strategic regulatory solutions to expedite your market access and ensure compliance with global standards. Our services are tailored to meet the unique needs of our clients:• Regulatory Strategy and Market Access• Regulatory Submissions and Compliance• Quality Management Systems (QMS)• Product Development and Lifecycle Management• Training and EducationAroyan Regulatory Consulting, Switzerland and the U.S.Phone: +41 78 217 95 35 +1 (925)520-5259Email: roya@aroyan.com

Design the curriculum for the Regulatory Science courses offered two semesters per year and teach multiple Regulatory Science courses, participate in generating the final exam question and reviewing the final grades. Industrial Advisory Board member in the University of Utah, Biomedical Engineering since August 2021.

Serve as a member of WW Business Group Leadership Team on preparation and Infusion delivery devices. Key contact for communication with the FDA, Notified Bodies as well global Health Authorities. Ensuring the achievement of business goals of obtaining MDR CE Certificates as well as clearances of multiple 510(k)s

Served as a member of Vascular Access Device Business Group Leadership Team on vascular access devices. Key contact for communication with FDA, NB as well global Health Authorities (HA). Laid successful strategies to integrate the MDD renewals and the EU MDR device registration path for the two subgroups of the business for the complex Class III, Class II, and Kit products.

• Provide leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide (US, EMEA, APAC and LATAM). • Assist in the compliance to the FDA, Medical Device Directive (MDD) in the EU, upcoming Medical Device Regulation (MDR), Canadian Medical Device Directive, and other regulatory agencies globally.

As the Strategic Planner:• Developed global regulatory strategies and update based upon regulatory changes.• Planed, directed, coordinated and controlled the regulatory affairs activities related to products globally both post market and premarketAs a strategic business partner, influenced at the divisional level and generally considered a key opinion leader and an expert resource both internally and externally.

• Responsible for development and implementation of global regulatory strategies for earliest possible approvals to support the company’s long term strategic plans. • Provided strategic input and technical guidance on regulatory requirements to the Research Programs, Development Projects and Life Cycle Management teams.• Responsible for Regulatory Affairs/Sciences, Design Control and QMS compliance for the Global R&D according to US FDA QSR 820 and ISO 13485.• Submitting and gaining U.S. approval for the new products, working directly with the US FDA on pre-IDE meetings, prepared and submitted a few IDEs, Pre-Submission Packages, 510(K) and PMA supplement submissions. • Responsible for gaining approvals from regulatory bodies and MOHs to introduce new products to EU, China, Japan and Korea and ROW by liaising with the regional regulatory team members. • In charge of Ad & Promo messages for all the new products.

• Responsible for the Regulatory Affairs/Science activities and QMS compliance for the Global R&D.• Responsible for the regulatory science activities for combination product. Submitted multiple RFD to the OCP.• Led the Global R&D QA team and support activities (team of 10) • Provided strategic input and technical guidance on regulatory requirements to the Global R&D’s New Technologies and development teams. • Developed and implemented strategies for earliest possible approvals to support business plans. • Generated clear definition of new product testing requirements, clinical trials and technical dossiers.• Worked directly with the US FDA on pre-IDE meetings, 510(K) and PMA supplement submissions. • Submitted and successfully gained approval for a USAN application.• Supported compliance with all US and International regulatory requirements pertaining to US FDA QSR 820 and ISO 13485. • Liaised with and facilitated the regulatory audits with the FDA and State of California FDB. • Actively participate in the New Product Development initiatives and the Life Cycle Management activities.• Author of multiple 510ks and PMA supplements for the U.S. FDA.

• Contributed directly to 510k submissions and CE registrations for multi-purpose solutions and dry eye products.• Expertise in translating regulatory requirements into practical paths. • Interacted directly with U.S. regulatory agencies. • Developed and implemented strategies for earliest possible approvals to support business and corporate objectives. • Provided leadership for regulatory agencies (ANSI, CLI, and ISO) on new Contact Lens Care standards initiatives.• Led the consumer products’ Microbiology group via ten direct reports. • Identified unmet ophthalmic product needs and market opportunities; coordinate with various R&D functions, Consumer Product Group, and consultants.

• Development, adaptation and utilization of biological assessment and methodologies to initiate pilot studies of new product opportunities for surgical therapeutic devices. • Identification of surgical adjunct product opportunities and concept verification using developed models.• Led a team of 9 experienced surgeons and scientists. • Identification of unmet ophthalmic surgical needs and market opportunities; coordinating with strategic marketing, strategic planning, customers, and consultants.