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Johnson & Johnson MedTech

Manager, QARA GCC Markets

Johnson & Johnson MedTech

Jeddah, Makkah Province, Saudi Arabia · 정규직

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경험
6–8 yrs
샐러리
채용 공고
1
게시됨
3주 전
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Qualified candidates with the required education and 6–8 years of relevant quality assurance and/or regulatory affairs experience in regulated industries can apply. Applicants should be comfortable working in an onsite role in Saudi Arabia, with English proficiency required and Arabic preferred. Li…
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About the company

Johnson & Johnson is a global healthcare leader focused on advancing innovation across medicines and medical technology. The company works to address complex diseases with smarter, less invasive, and more personalized solutions, aiming to improve health outcomes worldwide. It also emphasizes an inclusive workplace where individuals are respected, valued, and recognized for their contributions.

Role overview

The Manager, QARA GCC Markets will lead quality assurance and regulatory affairs activities across the Gulf Cooperation Council region. The role is centered on maintaining compliance, strengthening quality systems, and supporting market access for the Orthopedics portfolio. It also involves guiding registrations, lifecycle activities, and inspection readiness while working closely with local, regional, and global partners to support patient safety and business growth.

Key responsibilities

  • Direct quality assurance and regulatory affairs work supporting registrations, renewals, variations, and ongoing product lifecycle activities across GCC markets.
  • Maintain alignment with local and regional regulations, international standards, quality system expectations, and internal company policies.
  • Act as the main QARA contact for GCC markets, offering strategy, guidance, and hands-on execution support.
  • Manage submissions, technical files, renewal activities, and responses to questions raised by health authorities.
  • Work with teams across Quality, Supply Chain, Commercial, Legal, and Global QARA to support business goals and uninterrupted supply.
  • Track changes in regulatory and quality requirements across the GCC and evaluate their impact on products, supply, and operations.
  • Contribute to regulatory inspections, quality audits, and health authority assessments when needed.
  • Support continuous improvement efforts that strengthen QARA processes, efficiency, compliance, and readiness for inspections.
  • Help shape regional policy initiatives that affect business strategy, continuity, and growth.

Education and experience

A bachelor’s degree is required in Regulatory Affairs, Life Sciences, Engineering, or a closely related discipline. An advanced degree or a professional certification in Regulatory Affairs, Quality, or a related area is preferred. The role calls for 6–8 years of progressive experience in quality assurance and/or regulatory affairs within medical devices, healthcare, or another regulated industry.

Required skills and knowledge

The ideal candidate should have strong knowledge of GCC regulatory requirements, health authority procedures, and quality management system principles. Experience in managing registrations and lifecycle work across multiple markets is important, along with the ability to apply regulatory and quality rules to business and product decisions. Strong communication, collaboration, and stakeholder management skills are needed, as well as the ability to handle several priorities in a fast-moving, complex, matrixed environment.

Preferred background

Helpful experience includes work in emerging market regulatory and quality models, familiarity with global regulatory frameworks and harmonization efforts, and exposure to multinational or matrixed organizations. Experience with regulatory inspections, quality audits, or health authority interactions is advantageous, as is a track record of driving process improvement or regulatory/quality transformation initiatives. Regulatory Affairs or Quality certification such as RAC or an equivalent credential is preferred.

Other details

English is required for this role, and Arabic is preferred. Limited regional travel across GCC markets may be required. The employer is committed to equal opportunity hiring and inclusive interview accommodations for candidates with disabilities. The role is part of the DePuy Synthes careers family and is positioned as a people leader within the Regulatory Affairs group.

Additional information

Job function: Regulatory Affairs Group. Job sub-function: Regulatory Affairs. Job category: People Leader. Location listed in the posting: Jeddah, Makkah, Saudi Arabia. The description also references Riyadh, Saudi Arabia as the location for the position.

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