Manager, QARA UAE, Africa, Rest of MEA

Overview

Job Description

Job Overview

Key Responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities to support product registration, maintenance, and lifecycle management across UAE, Africa, and Rest of MEA markets.
• Ensure compliance with regional and country‑specific regulatory requirements, internal policies, and DePuy Synthes quality management system standards.
• Act as the primary QARA point of contact for assigned MEA markets, providing regulatory and quality guidance to local and regional stakeholders.
• Coordinate regulatory submissions, renewals, variations, and responses to health authority inquiries in collaboration with Global QARA teams.
• Partner with cross‑functional stakeholders including Commercial, Operations, Supply Chain, Legal, and Global QARA to support business objectives and supply continuity.
• Monitor regulatory, quality, and enforcement changes across MEA markets and assess potential impact to products, portfolios, and operations.
• Support and participate in audits, inspections, and regulatory or quality assessments as required.
• Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance consistency, and inspection readiness across the region.
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Qualifications

• *Education*
• Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.

Required

• *Experience and Skills*
• 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Strong working knowledge of regulatory requirements applicable to UAE, Africa, and broader MEA markets.
• Experience managing product registrations and lifecycle activities across multiple international markets.
• Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
• Strong stakeholder management, communication, and cross‑functional collaboration skills.
• Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.

Preferred

• Experience supporting emerging market QARA portfolios.
• Familiarity with global regulatory frameworks and harmonization initiatives.
• Experience working in a multinational or matrixed organization.
• Exposure to regulatory inspections, quality audits, or health authority interactions.
• Demonstrated experience contributing to process improvement or QARA transformation initiatives.
• Regulatory Affairs or Quality certification (e.g., RAC or equivalent).

Other

• Language: English required; Arabic and/or French preferred.
• Travel: Moderate international travel across MEA markets.
• Certifications: RAC or equivalent preferred but not required.
• Johnson & Johnson is an Equal Opportunity Employer.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
• We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
• Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.
• If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
• #DePuySynthesCareers

Preferred Skills