Farrukh Mohiuddin Email & Phone Number

MA, 01824, US

• Provide leadership to the regulatory and cross-functional teams on multiple product lines during product development, regulatory submissions,and post-market issues with effective and efficient regulatory strategy.
• Interpret regulations, laws, and guidance to establish, implement and monitor policies, procedures and processes to ensure compliance.
• Develop and execute sound regulatory strategies for a range of complex existing products and new product development programs, with emphasison regulatory requirements and submissions associated with FDA Class II and.
• Independently prepare global regulatory applications, including U.S. and E.U. MDR Medical submissions (Pre-market Approvals (PMA), PMAAnnual Reports, 510(k)s, E.U. MDR Technical Documentation - Class I-III, etc.).
• Demonstrate deep knowledge of the EU MDR and ensure applicable requirements are embedded in the QMS.
• Support global expansion of products through RoW submissions (i.e., S. Korea, Taiwan, India, Japan, etc.).

Victor, NY, US

Victor, NY, US

• Participating on product development teams by providing assessment of new devices, proposed changes or enhancements to existing devices, regulatory strategy, timelines, and deliverables ensuring proper European.
• Maintaining full Quality and Regulatory compliance with all standards that govern the design, development, manufacture, and distribution of LSI’s medical devices.
• Provide regulatory feedback and guidance to the company throughout the development cycle.
• Independently author, prepare, and compile regulatory documents for product submissions to one or more European Notified Bodies. Collaborate with appropriate departments to ensure applicable materials are developed to.
• Coordinating with other Regulatory members as needed to ensure reporting requirements regarding new and modified device requirements under other international standards/rules are met.
• Maintaining appropriate European registrations and product listings.

Victor, NY, US

• Participate in product development teams by providing assessment of proposed changes, regulatory strategies, timelines, and deliverables ensuring proper regulatory requirements (US/EU/RoW).
• Review and approve product and manufacturing changes to assess regulatory impact while considering global regulatory requirements.
• Author, prepare, and compile the submission files to obtain market approvals in the USA (510(k), Europe (MDD/MDR), and RoW ensuring all global requirements for market approval of medical devices.
• Support post-market surveillance by providing complaint metrics, trend analyses, and conducting vigilance and MDR reporting to regulatory authorities as required.
• Driving global harmonization of core labeling content review by assessing, approval, and release of product related labeling and marketing materials (i.e. IFUs, artworks, leaflets, brochures).
• Act as primary contact for receiving, processing, tracking, investigating, and reporting of customer complaints from initiation to closeout.

Victor, NY, US

• Managed a medical device testing & evaluation laboratory; maintained strict code-adhering safe and effective laboratory practices.
• Provided multidisciplinary/inter-departmental support with biologic tissue and device preparation for bench-top medical device testing.
• Dissected tissue for anatomical/clinical research and medical device testing.
• Assisted with planning and executing successful cadaver labs for purposes of medical device/clinical research and development.
• Supported FDA submissions through testing/acquiring relevant engineering data.
• Assisted with medical device post-market surveillance report data.

• Research of the application and feasibility of In-Silico (virtual) clinical trials
• MATLAB simulations of Ordinary Differential Equations for virtually obtaining hemodialysis data from the Vascular Refill model

• Developed upper extremity 3D-printed prostheses
• Responsible for the development and distribution of thirty prosthetic hands and three arms
• Fabricated a detachable scapular harness device for use with a prosthetic arm
• Manufactured method to create a comfortable prosthetic liner for patients’ residual limb using Silicone Rubber
• Assisted with the development of a 3D-printing and designing curriculum for a High School STEP program
• Presented to demonstrate the application and business prospect of 3D-printed prosthetics to traditional ones

• Provided Tutoring Services in Chemistry, Project-Based Calculus I & II, Differential Equations, and Multivariable & Vector Calculus
• Developed and executed customized study-plans for individual students

• Worked here as an intern:- Completed 400+ hours
• Assisted nurses by regularly monitoring patients and keeping them appraised of their condition
• Responsible for obtaining required medication for patients
• Filed and maintained patient records manually and electronically