Description
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 MedTech, 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Jeddah, Makkah, Saudi ArabiaJob Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.DePuy Synthes is recruiting for a(n) Manager, QARA GCC Markets, located in Riyadh, Saudi Arabia
Job Overview
The Manager, QARA GCC Markets provides operational leadership for quality assurance and regulatory affairs across the Gulf Cooperation Council (GCC). This role is responsible for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio.
This position plays a critical role in enabling compliant product registrations, lifecycle management, and inspection readiness while partnering closely with local, regional, and global stakeholders to support patient safety and sustainable business growth in the GCC region.
Key Responsibilities
Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and lifecycle management across GCC markets.
Ensure compliance with local and regional regulatory requirements, applicable international standards, quality management system expectations, and internal policies.
Serve as the primary QARA point of contact for GCC local markets, providing quality and regulatory strategy, guidance, and execution support.
Coordinate regulatory submissions, technical documentation, renewals, and responses to health authority inquiries.
Partner with cross‑functional teams including Quality, Supply Chain, Commercial, Legal, and Global QARA to support business objectives and supply continuity.
Monitor regulatory and quality requirement changes across GCC markets and assess potential impacts to products, supply, and operations.
Support and participate in regulatory inspections, quality audits, and health authority assessments as required.
Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance, and inspection readiness.
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.
Experience and Skills
Required:
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 GCC regulatory requirements, health authority processes, and quality system principles.
Experience managing product registrations and lifecycle activities across multiple markets.
Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
Strong stakeholder management, communication, and collaboration skills.
Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.
Preferred:
Experience supporting emerging market regulatory and quality models.
Familiarity with global regulatory frameworks and harmonization initiatives.
Experience working in multinational or matrixed organizations.
Exposure to regulatory inspections, quality audits, or health authority interactions.
Demonstrated experience contributing to process improvement or regulatory/quality transformation initiatives.
Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Other
Language: English required; Arabic preferred.
Travel: Limited regional travel across GCC 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.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team ManagementDePuy Synthes is recruiting for a(n) Manager, QARA GCC Markets, located in Riyadh, Saudi Arabia
Job Overview
The Manager, QARA GCC Markets provides operational leadership for quality assurance and regulatory affairs across the Gulf Cooperation Council (GCC). This role is responsible for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio.
This position plays a critical role in enabling compliant product registrations, lifecycle management, and inspection readiness while partnering closely with local, regional, and global stakeholders to support patient safety and sustainable business growth in the GCC region.
Key Responsibilities
Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and lifecycle management across GCC markets.
Ensure compliance with local and regional regulatory requirements, applicable international standards, quality management system expectations, and internal policies.
Serve as the primary QARA point of contact for GCC local markets, providing quality and regulatory strategy, guidance, and execution support.
Coordinate regulatory submissions, technical documentation, renewals, and responses to health authority inquiries.
Partner with cross‑functional teams including Quality, Supply Chain, Commercial, Legal, and Global QARA to support business objectives and supply continuity.
Monitor regulatory and quality requirement changes across GCC markets and assess potential impacts to products, supply, and operations.
Support and participate in regulatory inspections, quality audits, and health authority assessments as required.
Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance, and inspection readiness.
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.
Experience and Skills
Required:
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 GCC regulatory requirements, health authority processes, and quality system principles.
Experience managing product registrations and lifecycle activities across multiple markets.
Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
Strong stakeholder management, communication, and collaboration skills.
Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.
Preferred:
Experience supporting emerging market regulatory and quality models.
Familiarity with global regulatory frameworks and harmonization initiatives.
Experience working in multinational or matrixed organizations.
Exposure to regulatory inspections, quality audits, or health authority interactions.
Demonstrated experience contributing to process improvement or regulatory/quality transformation initiatives.
Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Other
Language: English required; Arabic preferred.
Travel: Limited regional travel across GCC 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.
#LI-Hybrid
#DePuySynthesCareers
