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.

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.

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..

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..

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.

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.

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