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 Class III devices.• 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.).• Support mergers and acquisitions from a Regulatory standpoint.• Review/approve marketing materials and labeling for regulatory requirement compliance.• Participate in regulatory inspections/audits by internal and external audit authorities.

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 governing requirements are incorporated as part of the development process for products targeted for Europe to ensure timely regulatory submissions and approval, including direct supervision of Regulatory Affairs Associates and/or Specialists assigned to the European Regulatory Team. • 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 enable European product market clearance, approval, and continuance during product life cycle. Assemble materials and data required for timely completion of European regulatory submissions: MDD/MDR, CE dossiers.• 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.• Applying scientific principles to understanding safety and efficacy of our products.• Provide guidance regarding the regulatory aspects of product design and development to include preliminary regulatory assessments, regulatory strategy, product labeling, indications for use, contraindications, etc.

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.• Prepare and submit timely customer response communications to report results of investigation per regulatory guidelines.• Monitor the global regulatory developments of new regulations, standards, policies, and guidances issued by regulatory authorities that may impact the company, existing products, and on-going product development.

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. • Planned timelines for medical device submissions to the FDA.

• 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• Maintained online presence of organization

• 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