Linde Middle East
Quality & Regulatory Affairs Manager - Middle East
Riyadh, Saudi ArabiaPosted 4 weeks ago
Apply link checked 2 days ago
- Salary
- AED 7k–9k a month· est.
- Job type
- Full time
- Level
- Lead
- Field
- Legal & Compliance
- Work mode
- On site
About the role
Linde Sigas Quality & Regulatory Affairs Manager - Middle East Saudi Arabia | req28801 What You Will Enjoy Doing • In this role, you will act in line with Linde's Integrity criteria and ensure compliance with medical Management System policies • You will conduct business trips for customer visits, audits, and compliance support • Manage administrative duties and training completion for Quality and Regulatory Affairs employees • And you will shape and implement quality strategies within REE and EMEA through leadership participation • Provide input to global Quality governance and promote Quality initiatives across regions • You will develop and adapt quality management tools and coordinate working groups at regional and global levels • Lead Quality and Regulatory Affairs activities in the Middle East, supporting new countries in policy adoption • Build and lead a competent QRA team, fostering professional development and regulatory compliance • Audit and monitor Quality Management Systems, driving continuous improvement and supplier compliance • Negotiate with regulatory bodies to influence medical gases and devices requirements and decide on non-compliance issues to protect patient safety What Makes You Great • You have expertise in regulatory affairs, quality, pharmacovigilance • Exposure with cross cultural teams, external partners, authorities, governmental bodies and associations • Familiar with complex matrix structures, ideally beyond business segments • Fluent in English is required for this role • Lean/six sigma qualification is an asset • You hold an University bachelor/master’s degree in Pharmaceutical or equivalent • Experience/studies in pharmaceutical or medical devices industry experience in the implementation and maintenance of Quality Management Systems, preferably more than three (3) years Why you will love working with us Thinking outside of the box, working on new topics and concepts, deliver great solutions to our internal customers is essential to bring success to our business. We will offer you a variety of possibilities to excel in your area of expertise. You will contribute towards making Linde an inclusive and diverse organization, creating innovative practices and fostering an environment that welcomes all differences – making Linde an employer of choice. What we offer you! At Linde, the sky is not the limit. If you’re looking to build a career where your work reaches beyond your job description and betters the people with whom you work, the communities we serve, and the world in which we all live, at Linde, your opportunities are limitless. Be Linde. Be Limitless. Working in Linde means to be in a workplace; where the safety is the first priority. Acting responsibly towards human, nature and society is our commitment. You will be surrounded by qualified teams which consist of experts and have many learning and development opportunities in every sense in an open communication culture. Have we inspired you? Let´s talk about it We are looking forward to receiving your complete application (motivation letter, CV, certificates) via our online job market. Any designations used of course apply to persons of all genders. The form of speech used here is for simplicity only. Linde Sigas acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.
Requirements
Experience in pharmaceutical or medical devices industry; more than three (3) years of experience implementing and maintaining Quality Management Systems. University bachelor/master’s degree in Pharmaceutical or equivalent. Fluent in English. Lean/Six Sigma qualification is an asset.
Responsibilities
Lead Quality and Regulatory Affairs activities in the Middle East, supporting new countries in policy adoption; Audit and monitor Quality Management Systems, driving continuous improvement and supplier compliance; Build and lead a competent QRA team, fostering professional development and regulatory compliance; Negotiate with regulatory bodies to influence medical gases and devices requirements and decide on non-compliance issues to protect patient safety; Develop and adapt quality management tools and coordinate working groups at regional and global levels; Provide input to global Quality governance and promote Quality initiatives across regions; Shape and implement quality strategies within REE and EMEA through leadership participation; Manage administrative duties and training completion for Quality and Regulatory Affairs employees; Conduct business trips for customer visits, audits, and compliance support.
Skills
- Regulatory affairs
- Quality management systems
- Pharmacovigilance
- Lean Six Sigma
- Regulatory negotiations
- Good practices/audit (GxP)
- Quality governance
- Supplier compliance
- Medical gases and devices regulations
- Quality tools development
- Team leadership
- English language
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