Senior Regulatory Affairs Specialist | Johnson & Johnson MedTech | UAE

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Senior Regulatory Affairs Specialist.

Purpose:

The main task of aSenior Regulatory Affairs Specialist will be to provide regulatory support for the countries in the Gulf Levant and Iraq region for DePuy Synthes business. You will partner with marketing sales operations and other teams as well as manage regulatory submissions in compliance with local country requirements.

You will be responsible for:

• Forecast & plan annual submissions according to business priorities and in collaboration with marketing and commercial colleagues.

• Responsible for product lifecycle management of the portfolio under scope of responsibility by planning and coordinating requirements for compiling submission dossiers for all types of regulatory activities according to each countrys rules and regulations including new products registration re-registration listing changes and custom clearance.

• Ensure timely submission follow up and approval of submitted registration/market authorization applications through collaboration and communication with distributors in local markets ensuring timely launch of NPIs and NPDs and full regulatory compliance of registered products at all times ensuring compliant business continuity.

• Effectively communicate and collaborate cross functions with internal stakeholders including sales and marketing teams to understand business priorities support and provide regulatory documents to support tender requests understand and communicate accurately regulatory requirements to global regulatory affairs teams.

• Build a strong relationship with external stakeholders including distributors in the countries by conducting follow-up meetings to ensure continuous progress of open applications and obtaining timely approvals as needed provide training and knowledge on internal processes products and common documentation.

• Conduct FSCA FSN and complaints reporting activities according to each countrys regulations.

• When necessary conduct copy review of marketing materials and submit for Health Authority approval in countries where it is applicable.

• Maintain all internal databases up to date as per internal SoPs.

• Can anticipate and flag risks to relevant stakeholders when necessary along with providing proposed solutions and action plan.

Qualifications / Requirements:

Education:

• Bachelor degree of Pharmacy Medicine Biomedical engineering or Sciences.
  

Experience and Skills:

• Proficiency in Arabic and English is a must.

• Minimum of 4 years of experience in a similar Regulatory Affairs position is a must preferably in Medical Devices Multinational Company required with regional regulatory scope.

• Has the ability to define and change priorities and still manage tasks as business activity dictates.

• Strong organizational skills and ability to plan and manage own work agenda independently.

• Big picture orientation.

• Results and quality driven candidate with great problem-solving skills.

• Proficient in Microsoft office with strong working knowledge of Word and Excel..

• Flexible to travel when needed.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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