Senior Regulatory Affairs Specialist | MedTech | UAE

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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 humanity.

Learn more at

• Job Function: Regulatory Affairs Group

• Job Sub Function: Regulatory Affairs

• Job Category: Professional

• All Job Posting Locations: Dubai, United Arab Emirates

Fueled by innovation at the intersection of biology and technology, we’re 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

Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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

We are searching for the best talent for
Senior Regulatory Affairs Specialist.

Purpose:

The main task of a Senior 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 country’s 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 NPI’s and NPD’s 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 country’s 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 SoP’s.

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

Education:

• Bachelor degree of Pharmacy, Medicine, Biomedical engineering or Sciences.

Experience and Skills:

• Proficiency in Arabic and English is a must.

• Min…