Feroz Mohammed Email & Phone Number

United Kingdom

• Economic operators’ registration on EUDAMED for J & J franchise, multiple Actor’s registered (Sponsor/ Manufacturers/ Importers).• Creation Management of EUDAMED related GxP training curricula affected functions/teams.• Ensuring J&J EUDAMED processes and documents satisfy the requirements of EU-MDR and needs of the business.• Work with Security Analysis team to ensure appropriate control of sensitive data and compliance to EU and J&J procedures.• Supporting and advising documentation changes in relation to EUDAMED when acquisitions and divestitures occur• Reviewing EUDAMED related changes and ensuring that risks are identified and managed; and that interdependencies between EUDAMED modules are identified and resolved.• Support regression testing following EUDAMED updates.• Supporting and coordinating reporting feedback between J&J and the EU Commission in relation to EUDAMED technical issues• Co-ordinating Gap Assessments ( MDR third amendment) and functional assessments, tracking resulting deliverables within EtQ.

United Kingdom

OVERALL RESPONSIBILITIES: • Serves as a consultant and technical expert on Regulatory Affairs matters. • Under little to no supervision provides assistance in preparation and submission of global regulatory documents. (Life Cycle Management MDD to MDR (CE marking), BSI submission, 510K submission to FDA, Global impact assessment).POSITION DUTIES & RESPONSIBILITIES: • Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities.• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. • Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. • Defines data and information needed for regulatory approvals. • Develops labelling specifications and approves proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations. • Provide Regulatory Affairs support during internal and external audits. • Plans schedules for regulatory deliverables on a project and monitors project through completion. • Assists in the development of best practices for Regulatory Affairs processes. • Represents Regulatory Affairs on cross-functional project teams. • Partners with other functions to define and obtain data to assist with regulatory submissions.• Provides regulatory support for selected regions and key customers in those regions,including defining local regulatory strategies, managing, planning, and submitting.

London Area, United Kingdom

• Provides regulatory support for selected regions and key customers in those regions,including defining local regulatory strategies, managing, planning, and submittingregulatory applications and technical documents, in conjunction with businesspartners, where appropriate, and communicating with local regulators, businesspartners and other parties.• Look after medical devices within the product portfolio including advising theengineering and product teams on regulatory views of new products, features orproduct changes, signing of major and minor releases, maintaining the devicehistory file and technical documents of the products.• Provide regulatory expertise on the local in country regulations, environment andtimelines to meet global launch plans.• Establishing and managing regulatory processes such as regulatory intelligence orcontent review, including the documentation of such processes.• Analyse complex regulatory frameworks and design submission strategy ensuringthere are no regulatory hurdles to go to market.• Review and approving advertise / promotional materials.• Managed and assisted in complying with the Usability Engineering BS EN 62366standard.• Working closely with commercial teams ensuring the local regulations are met andmeets the launch plans.

United Kingdom

• Responsibility of registration and post market of all class of medical devices within the EEMEA region (MENA region) falling under Therapeutic areas (Peripheral vascular, Access, Urology, Biosurgery, Hernia repair, Biopsy and surgical instruments etc.) • Work with Divisions and Bard business units to obtain registration dossiers and ensure it meets the country specific format as per local registration requirements, submit applications to relevant MoH/CA.• Maintain records and tracking of registrations by creating licence records, registration activity and quality activities on the sales force tracking system to alert in advance per licence expiry.• Support the international team, e.g., by executing regulatory strategies and registration timelines; by monitoring and communicating regulatory intelligence and assessing its potential impact; by assuring that product to be registered meets country regulatory requirements.• Product change impact assessment lead for the EEMEA region, its impact to country registrations and ensure licences renewed with no impact supply chain and regulatory compliance.• Support post market activities including product registrations, renewals, complaint reporting and field safety corrective actions (FSCA) including product recalls, as needed for countries in scope.• Experience with Saudi SFDA registrations, Israel, Iran, IRAQ, Lebanon, Egypt, North Africa countries and others within MENA region.• Understand and recommend regulatory strategies based on current local registration requirements and applicable industry standards.• Prepare appropriate export application forms for products intended to be exported to foreign countries (CFG/FSC, Certificate of Exportability)• Ensure product is released to the market as per the launch plans.• Regulatory lead for product holds and releases (regulatory compliance is maintained).• Travelled to meet MOH’s, dealers and internal, external business meetings.