Regulatory Affairs Specialist

Job Description

Johnson & Johnson Medical is recruiting for Regulatory affairs Specialist to be located in Cairo, Egypt. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It?s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities. Summary of the job: The main task of a Regulatory Affairs Specialist in Johnson & Johnson is to: Provides regulatory support for the countries in the region. Provides advisory support to marketing, sales, operations, other company stakeholders. Managing regulatory submissions (new and renewals) in compliance with local country requirements. Contribute to day-to-day requests from Sale and Marketing colleagues. Duties & Responsibilities Plan and coordinate the requirements for compiling technical dossiers as part of regulatory submissions for new product registration and renewal of existing registrations. Communicate all requirements to the global Regulatory Affairs team. Track and follow up in a timely manner to ensure deadlines are met. Review, secure approvals and make submissions for Marketing Authorization / registration applications / listings. Manage regulatory aspect of Product Life Cycle by ensuring updated and obsolete products are handled appropriately internally and externally. Providing the required support for the distributors in local markets to ensure regulatory compliance with local legislation requirements. Preparing appropriate documentation and, where required, making submissions for authorizing distributors (Authorized Representative License) to represent the company in the area of operation. As required, conduct complaint handling activities and report to appropriate local health authority and closeout potential reportable complaints as required for the region. Support region sales and marketing requirements, including contribution to tender process, responding to requests for documents and, if required, draft responses to specific questions. Other duties may be assigned. Qualifications Experience Required Bachelor degree in Pharmaceutical Science, or Biomedical Engineering 3- 5 years experience of Medical Devices Regulatory Framework Experience in a Medical Devices Multinational Company Middle East Regional Regulatory Experience Qualifications & Skills Knowledge in the international regulations of Medical Devices required. Ability to define and change priorities and still manage tasks as business activity dictates and a willingness to learn new concepts / tasks. Excellent technical writing and oral communication skills with English & Arabic languages an essential Demonstrated interpersonal flexibility and strong team skills. Strong organizational skills and ability to plan and manage own work effort. Proven ability to exercise good judgement. Reputation of being results and quality driven. Possess problem solving skills. Proficient keyboard and computer skills including excellent knowledge of Excel and MS Word, or equivalent spreadsheet, and word processing applications. Numerate and accurate, particularly in relation to data entry and data integrity. Leadership Behaviors Required LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose CONNECT: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player. SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change. Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Egypt are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means ?You Belong?! Primary Location Egypt-Cairo-New Cairo- Organization Johnson & Johnson for Exp (7069) Job Function Regulatory Affairs Requisition ID 2206033713W

Keyskills :