Suhail Abdullah Email & Phone Number

California, United States

• Plan, author, and update CERs and post market surveillance documentation (CERs, CEPs, PMSPs, PMSRs, PMCFPs, PMCFRs, SSCPs, PSURs) for products.• Internal SME on clinical evidence for products and competition supporting needs of other departments for clinical data. • Create SOPs and forms for CERs and post market surveillance activities.• Manage transition from MDD to MDR. Ensure regulatory compliance and adherence to standards and guidelines (EU MDR 2107/75, MEDDEV 2.7/1 Rev 4, MEDDEV 2.12/1 Rev 8, Relevant MDCGs, ISO 20416/2020). • Conduct thorough research on the subject devices and state of the art. • Design and perform compliant and sustainable systematic literature searches and reviews of the subject devices and SoA. • Analyze data and form conclusions validating safety, performance, and overall benefit-risk profile. Interpret trends and communicate findings to support regulatory submissions. • Project management for PMSP activities with cross-functional team. Ensured compliance of all activities.

Rancho Cucamonga, Ca

Pre-clinical study management – Oversight of animal studies during product feasibility and development including GLP validation studies. Manage CROs, histopathology labs, and surgeons. Consult with FDA reviewers on study design and execution. Write protocols/reports in compliance with standards. Clinical Evaluation Reports (CER) - Author and maintain all product CERs including implantable devices. Manage transition from MDD to MDR regulations. Update SOPs and forms for MDR compliance. Post Market Surveillance - Regularly conduct and documented post market surveillance activities as required by 93/42/EEC Medical Device Directive (MDD) and outlined in ISO 13485 and ISO 14971. This includes review of MAUDE and other surveillance databases and clinical literature review of products and competitors.

Rancho Cucamonga, Ca

o Technology scouting - Assessed and screened dozens of technologies for clinical, technical, and strategic fit to feed product pipeline. Developed online idea gateway. Identified relevant applied research for existing product lines. Explored opportunities to license/partner with other entities such as inventors, universities, and other businesses. Identified regulatory barriers utilizing FDA pre-submission process. Managed technology review board. Advised inventors / entrepreneurs on business plans and strategyo KOL managemento Competitive intelligence / analysis - mapped and monitored competitive landscape for executive teamo Clinical education support

Rancho Cucamonga, Ca

Clinical and Medical Affairso Established clinical/medical affairs department which oversaw multiple post market clinical studies including prospective, retrospective, comparative, and investigator-initiated studies. o Presentations/posters at all major ophthalmic meetings for company. o Created and oversaw first clinical advisory board for company. Cultivated relationships with KOLs and advocateso Rewrote all company product IFUs ensuring compliance with regulatory requirements/standards for product labeling. o Responsible for post market surveillance program o Clinical Evaluation Report (CER) author for newest glaucoma device per MEDDEV 2.7.1Regulatory Affairso Led activities to obtain FDA 510(k) clearance for market leading glaucoma drainage device. Prepared FDA submission and represented company with FDA. o V&V protocols, biocompatibility evaluation.o Created US/CE regulatory strategy for products in pipeline.

Rancho Cucamonga, Ca

Project lead for minimally invasive glaucoma deviceo Technology scouting and evaluationo Option and license negotiation o Brainstormed and contributed ideas to strengthen IP position. o Project planning o Upstream marketingo Developed design requirements and regulatory strategy. Risk management.o Verification & Validation testing o Trained surgeons and sales representativeso Organized and managed first in man clinical evaluations, data collection, analysis, and publication planning. Innovation - screened any new internal/external product ideas. Developed technology screening process assessing strategic, technical, sales fit including clinician feedback. Quality system - Wrote SOPs for design controls, change control, risk management, and process validations. Answered technical/clinical questions posed by auditors.Responsible for post market surveillance activities.

Project Lead - Class II Glaucoma Drainage Deviceo Coordinated all project activitieso Obtained Phase II SBIR 2-year grant for project. o Product development and process development including prototyping, V&V testing, management of animal study, and supplier management.o Prepared 510(k) submission and received FDA clearanceo Product launch activities including training, OR visits, and clinical educationGlaucoma device research including proof of concept testing, design and process development, cutting edge materials and coating, drug delivery device prototyping, and custom devices. Collaborated with clinicians, university researchers, and other small companies. Production and Sustaining Engineeringo Created test benches and overhauled in-line inspection/test methods and set appropriate control limits to better align with clinical performanceo Improved yield, implemented tool maintenance program to control processo Managed suppliers and changes in manufacturing processes/toolso Troubleshooting any issues in manufacturing process. Responsible for all post market surveillance activities

Greater Los Angeles, California, United States

Greater Los Angeles Area

Apparel & Household GoodsAmazon private label seller-4 brands-best selling product in product category and Amazon's choice-multiple listings in top 100 of category-#1 New Release in product categoryShopify, Walmart.com, Etsy (Bestseller), Ebay

Greater Los Angeles, California, United States

E-Commerce Dietary Supplements, Amazon, Shopify.Directed team in execution of business plan. Led strategic planning, product development, launch, supplier and inventory managementManaged financial operations

California

Independent business/regulatory consultant focused on medical device start-upsFormulating efficient regulatory strategiesFDA Pre-submissions and 510(k) submission preparationInterfacing with FDAAdvising clients about QMS regulations, standards/guidance documents, product development, outsourcing, design controls, risk management, and performing gap analysis

Master Of Business And Science, Biotechnology - Medical Devices

Bachelors, Cybernetics - Bioinformatics