Regulatory Affairs Gulf Levant and Iraq Lead | Johnson & Johnson MedTech | UAE

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We are searching for the best talent for Regulatory Affairs Gulf levant and Iraq Lead.

Purpose:

The role of Regulatory Affairs Gulf Levant and Iraq is to ensure timely registration of medical devices in accordance with National Legislation in Gulf levant and Iraq and compliant placing medical device products on the market relevant to business strategy. The Regulatory Affairs slead role will conduct product registration preparation and submission in compliance with applicable law, internal regulatory processes and procedures.

This role to support regulatory matters and projects and involved in RA policy shaping – outreach and Regional RA strategy alignment.

You will be responsible for:

• In charge of regulatory shaping and outreach coordination in respective regions, closely interacting with local Regulatory authorities and Trade Associations.

• Setting up annual regulatory submission plans by coordinating between local business/regional leads and franchise regulatory affairs considering regional and portfolio priorities.

• Preparing documents for registration submissions to health authorities for direct and indirect submissions via local authorized distributors.

• Ensuring regular interaction with key stakeholders to maintain compliance with relevant regulations

• managing the submission process and providing follow-up until the registration process for each product is completed.

• When required, to flag and escalate potential risks to business (marketing, supply chain - sales), share experience and recommend actions to support the business continuity without interruption.

• Assess impact of regulatory changes on products, business/licenses and patients.

• Interfaces with RA team members (Franchise and Regions), commercial partners to oversee the regulatory aspects for proactive involvement.

• Ensures regulatory compliance of medical devices and medicinal in product portfolio of JnJ MedTech, within timelines.

• Provides RA support to Tender management, importation and Reimbursement, Business, Distributors, and Franchises.

• Leads ongoing efforts to improve RA processes.

• Ensures audit readiness in RA area and represents RA during the audits and HA inspections.

• Provides routine communication and updates to management on regulatory compliance.

• Coordinates and manages Copy Review process.

• Provides feedback to operations on problems related to regulatory compliance and ensures timely and consistent escalation of events.

• Manages work and performance of direct reports.

• Identifies opportunities for cost saving and involves financial value

• Meets all applicable quality, legal and HCC compliance requirements

• Performs other work-related duties as assigned by manager.

Qualifications / Requirements:

• Years of Experience : Generally Requires 4-6 Years Work Experience

• Education: University/Bachelors science /Biomedical Degree or Equivalent

• Language: English & Arabic

• Makes decisions based on local requirements – to execute effectively.

• Demonstrates RA requirements and communicates regulatory and compliance needs to Business

• Displays expertise in local and EU Medical Devices regulations

• Relationship and network of contacts in the Competent Authorities and Trade Associations

• Excellent interpersonal skills - building and maintaining relationships with internal and external partners

• Excellent organizational skills and attention to details.

• Results & Performance Driven

• Sense of Urgency

• Strategic Thinking

• Accurate and intuitive problem solving, critical thinking, conflict management

Required Skills:

Preferred Skills:

Compliance Management, Consulting, Design Thinking, Detail-Oriented, Developing Others, Inclusive Leadership, Leadership, Operational Excellence, Operations Management, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented, Sustainability, Sustainable Packaging, Team Management