Regulatory Affairs & Quality Specialist (Saudi National Only)
SIEMENSRiadUpdate time: June 1,2022
Job Description
Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Regulatory Affairs & Quality Specialist (Saudi National Only) Our global team: Siemens Healthineers is a leading global medical technology company. 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. Our culture: Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. Your tasks and responsibilities: Ensure compliance with applicable SFDA requirements and Siemens Healthineers requirements. Independently coordinate and track product licensing activities including the gathering of documents and the submission of registration documents. Monitor progress of applications against set timelines, interact with SFDA where necessary, to expedite the approval and anticipate difficulties/challenges. Handle all post-market requirements for Medical Devices in timely manner and ensuring internal & external requirements are met. This includes Adverse Event reporting and Field Safety Corrective Actions where required. Monitor the regulatory environment and provides assessments of the impact of new and changing regulations for the company. Act as contact person for SFDA Ensure good documentation practices, maintain regulatory files relevant to company & products licenses and reporting of adverse Event and Field Safety Corrective Actions. Ensure compliance with Quality standards as well as company guidelines. Lead and drive compliance to quality system processes, like continuous improvement process, QMS training, audit process, CAPA management, complaint handling, Quality KPIs etc…, Ensure compliance with national and international EHS standards as well as company EHS guidelines. Your qualifications and experiences: You have an academic degree in engineering and bring minimum 3 years' professional experience in regulatory affairs with SFDA. Experience in QEHS Management related to medical devices. You have an in-depth understanding of international medical device requirements Certification in Regulatory Affairs Certification as ‘Certified Quality Manager’ and ‘Certified Quality Auditor’ are desirable EHS certifications are desirable Your attributes and skills: You are a team player with good social and communication skills, enabling you to inspire other people with your ideas and to develop new ideas with them Your personal strengths include an analytical mindset, empathy, a focus on results, and personal initiative, and you are able to resolve complex technical and process-related issues Your skills also include good moderation and presentation techniques You are business-fluent in written and spoken English GDPR We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Diversity and Inclusion Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, and other categories protected by federal, state or local law. Organization: Siemens Healthineers Company: Siemens Healthcare Limited Experience Level: Experienced Professional Job Type: Full-time

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