Regulatory Affairs Specialist Missa

**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.

With $70.1 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices, and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching 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.

**Sector/Organization Overview**:
Johnson & Johnson Medtech

**Summary of the job**:
MISSA is of strategic focus for the company, it is characterized by the rapidly evolving and complex Regulatory Environment, the aim of this role is to manage all aspects of regulatory activities for the region of Maghreb, Sub Sahara Africa and IRAN including but not limited to: dossier preparation for new product registration, Renewals, changes submission and follow up, respond to tender requests, copy review, customs clearance and reportability of adverse events.

Work efficiently with external and internal stakeholder to provide required regulatory input to achieve regulatory goals and objectives and overall company goals.

**Duties & Responsibilities**:

- Ensures that the license for distribution of medical devices is maintained / updated appropriately.
- Provides the necessary regulatory support for importation requests.
- Ensures proper maintenance of product documentation and local Regulatory document database
- Leads efficient and constructive communication with internal and external stakeholder (cross function - Franchise - distributors)
- Responds to tender requests within the communicated timelines
- Responsible for copy review and approval in line with internal JnJ standards
- Responds to Franchise RA requests related to the regulation and registration requirements in the region.
- Efficient communication with internal and external stakeholders
- Works in compliance with the current SOPs and should be able to update the same according to business need.
- Understand the regulatory environment of the region and keep all relevant stakeholders updated with the new guidelines and regulation impacting the business and registration timelines.
- Assesses the impact of the various changes that a product may undergo during its life cycle and implements the actions necessary to maintain registration in the target countries.
- Assesses and decides whether or not Materiovigilance incidents are reportable and reports and follows up with local authorities if needed.

**Main performance measures (Performance Goals)**
- Project Management, planning, execution and follow up.
- Business Plan support in term of Registration and providing the regulatory support to ensure business continuity and no business interruption due to regulatory reasons.
- Monitoring and shaping the external regulatory environment, especially distributors and Health Authorities
- Working closely with regional RA team, commercial and market to support business plan and strategic goals for the region.
- Execute the Regulatory strategy defined by the global/regional leaders.

**Qualifications**:
**Experience Required**:

- Education: Medical/Scientific/Pharmaceutical Background
- Years of Experience: 3-6 in Regulatory Affairs medical devices is a must have
- Experience in multinational medical devices company is prefered
- Language: English, Arabic is a must and French (optional)
- Location: Egypt

**Leadership Behaviors Required**:

- **LIVE OUR CREDO**:Demonstrate and inspire the behaviors that reinforce Our Credo.
- **CONNECT**:Develop deep insights into the needs of our patients, customers, markets, and communities.
- **SHAPE**:Drive innovation; anticipate and shape industry and market changes to advance health care globally.
- **LEAD**:Create an environment where leadership and talent development is top priority.
- **DELIVER**: Deliver results by inspiring and mobilizing people and teams.

**Technical/Functional Skills Required**:

- Regulatory Affairs
- English, Arabic is a must and French (optional)
- Medical/Scientific/Pharmace