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. This role is only 12
months fixed term contract.
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
Qualifications
Experience Required
- Education: Bachelor's (B.Sc.) Degree of Pharmaceutical or Sciences
- Experience: Minimum. 2 years - In Medical Device Product Registration.
- knowledge of SFDA Regulation sand Guidelines for Medical Device
- knowledge of Product Registration Submission - Medical Device
- Language: English - Arabic
- Location: Riyadh .Saudi Arabia
- Relocation availability: NA
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.
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.