Manager, QARA GCC Markets

DePuy Synthes is recruiting for a(n) Manager QARA GCC MarketslocatedinRiyadh 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 roleis responsible forensuring regulatory compliance effective quality management system execution and sustained market access for DePuy Synthes Orthopedics portfolio.

Thisposition 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 crossfunctional teams including Quality Supply Chain Commercial Legal and Global QARA to support businessobjectivesand supply continuity.

• Monitor regulatory and quality requirement changes across GCC markets and assess potential impactstoproducts supply and operations.

• Support andparticipatein regulatory inspections quality audits and health authority assessments as.

• Contribute to continuous improvement initiatives to enhance QARA processes efficiency compliance andinspectionreadiness.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.

Qualifications

Education

• Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.

• Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.

Experience and Skills

Required:

• 68 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 fastpaced 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; Arabic preferred.

• Travel:Limitedregional travel across GCC markets.

• Certifications: RAC or equivalent preferred but not.

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 internal employees contact AskGS to be directed to your accommodation resource.

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