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2 часа назад

QA/RA Specialist II (MedTech)

Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
SA
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
QA/RA Specialist II (MedTech): Supporting quality assurance and regulatory affairs activities for medical device products across Egypt and other Middle East and Africa markets with an accent on regulatory submissions, product registrations, quality systems, and compliance. Focus on maintaining inspection-ready records, assessing regulatory changes, coordinating audits and post-market activities, and enabling compliant product commercialization.

Location: Jeddah, Makkah, Saudi Arabia; the job description also references Riyadh, Saudi Arabia. Hybrid work; limited travel may be required.

Company

Johnson & Johnson MedTech develops healthcare and orthopedic solutions, including DePuy Synthes products.

What you will do

  • Support preparation, submission, and maintenance of regulatory documentation for Egypt and other Middle East and Africa markets.
  • Provide expertise on local regulatory and quality requirements in the countries within scope.
  • Execute Quality Management System processes, including document control, change management, and records maintenance.
  • Coordinate product registrations, renewals, post-market changes, audits, and inspections with regional and global QARA partners.
  • Monitor regulatory changes and assess their impact on current and future products.
  • Collaborate with Commercial, Supply Chain, and other stakeholders to support compliant product commercialization.

Requirements

  • Bachelor’s degree required; Life Sciences, Engineering, Pharmacy, or a related discipline is preferred.
  • Typically 2–4 years of relevant experience in Quality Assurance, Regulatory Affairs, or a regulated healthcare or medical device environment.
  • Working knowledge of quality systems and regulatory processes in a regulated industry.
  • Ability to follow defined procedures, execute processes accurately, and manage multiple priorities.
  • English required; Arabic is preferred.
  • Experience with regulatory activities in the scope countries, medical device regulations, audits, inspections, and matrixed global organizations is preferred.

Nice to have

  • Regulatory or Quality certifications such as RAC or ISO-related certifications.
  • Experience supporting additional Middle East markets.
  • Exposure to internal or external audits and inspections.

Culture & Benefits

  • Inclusive work environment focused on employee diversity, dignity, and equal opportunity.
  • Opportunity to support patient access to orthopedic healthcare solutions across the region.
  • Collaboration with regional and global partners in a matrixed organization.
  • Employment and benefit processes may transition to DePuy Synthes following the planned orthopaedics business separation, subject to applicable approvals and consultations.

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