Job Description

Johnson & Johnson 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 Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance. Duties & Responsibilities Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable SFDA meetings. Clearance support to distributers. Updating the regulatory tracking systems Having the renewed certificates & re-registration licenses of expired ones on time. Responding to Change Impact Assessments before due dates. Doing Copy Review process for promotional materials on time upon request. Lift all regulatory restrictions for products that can be shipped to Saudi Arabia Tender support to commercial teams & distributers Main performance measures (Performance Goals) Interaction with: Business partnering (Sales, Marketing) Supply Chain Health Authorities Local Distributors Global Regulatory Affairs

Experience Required Education: Bachelor's (B.Sc.) Degree of Pharmaceutical or Sciences Experience: minimum 2 years of experience in Medical Device Product Registration is a must have Knowledge of SFDA Regulation and Guidelines for Medical Device is a must have Experience working in multinational healthcare industry is highly preferred knowledge of Product Registration Submission - Medical Device is a must have Language: English - Arabic Location: Riyadh .Saudi Arabia 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. Technical/Functional Skills Required Other Job Specific Skills: Sense of Urgency. Attention to Details. Collaboration & Teamwork. Self-Motivation. Creative problem-solving. Working under stress. Good Level of Communication. Proper Planning. Key Competencies or Skills Required:

Time Management Presentation & Communication Skills Involvement in Regional Projects. Travel: