Director, QARA MEA, Distribution & Ops
ملخص الوظيفة
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Dubai United Arab Emirates Oberdorf Basel-Country Switzerland Zuchwil SwitzerlandJob Description:
DePuy Synthes is recruiting for a Director QARA MEA Distribution & Ops located in Dubai UAE or Zuchwil Switzerland or Oberdorf Switzerland.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):
Dubai UAE- Requisition Number: 074422
Loughbeg Ringaskiddy Switzerland - Requisition Number: 077221
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Job Overview
The DirectorQARA MEAprovides senior leadership for quality assurance and regulatory affairs across the Middle East and Africaregion.This role is accountable for ensuring regulatory compliance effective quality management system execution and sustainable market access across a diverse and complex set of markets.
This positionplays a critical role in safeguarding patient safety enabling compliant growth and ensuring business continuity across MEA. The role partners closely with Commercial Operations Supply Chain Legal and Global QARA leaders to manage quality and regulatory risk while supporting product lifecycle excellence.
Key Responsibilities
Lead and execute the Quality Assurance and Regulatory Affairs strategy across MEA markets in alignment with global QARA objectives and international business priorities.
Ensure ongoing compliance withcountryspecific regulatory requirements applicable international standards internal policies and DePuy Synthes quality management system requirements.
Provide strategic quality and regulatory guidance to support product registrations renewals variations and full lifecycle management across the region.
Serve as the senior QARA escalation point for MEA Local Market Support addressing regulatory quality and compliance risks.
Partner with crossfunctional stakeholders including Commercial Operations Supply Chain Legal and Global QARA to support product launches supply continuity and portfolio optimization.
Monitor interpret and communicate regulatory quality and enforcement trends across MEA proactively assessing business and patient safety impact.
Oversee and lead regulatory inspections quality audits and health authority interactions across the region ensuringtimelyand effective responses.
Drive continuous improvement harmonization and simplification of QARA processes across MEA markets.
Lead coach and develop regional QARA leaders and teams fostering a strong culture of quality compliance accountability and performance.
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.
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:
1012 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries.
Strong working knowledge of regulatory requirements quality system standards and enforcement practices across MEA markets.
Demonstrated experience leading multicountry or regional QARA portfolios.
Proven ability to develop and execute integrated quality and regulatory strategies aligned with businessobjectives.
Experienceoperatingeffectively in global matrixed organizations with senior executive stakeholder engagement.
Strong leadership presence sound judgment and decisionmaking capabilities in complex regulatory environments.
Preferred:
Experience supporting emerging market QARA operating models.
Experience working in multinational or matrixed organizations.
Direct exposure to regulatory inspections quality audits and health authority negotiations.
Demonstrated success driving QARA transformation process improvement or operating model change.
Background in orthopedics medical devices or other highly regulated healthcare environments.
Regulatory Affairs or Quality certification (e.g. RAC or equivalent).
Other
Language: English;additionalregional languages preferred.
Travel: Moderate regional and occasional international travel across MEA 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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Required Skills:
Preferred Skills:
Business Writing Collaborating Compliance Risk Continuous Improvement Developing Others Fact-Based Decision Making Inclusive Leadership Industry Analysis Innovation Leadership Legal Support Operations Management Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Strategic ThinkingRequired Experience:
Director
عن الشركة
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... اعرض المزيد