Description
Together, we can beat cancer.
At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
If you want to be part of this important mission, we want to hear from you.
Job Responsibilities:
- Performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections.- Compiles all materials required in submissions, license renewal and annual registrations.- Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.- Monitors and improves tracking/control systems.- Keeps abreast of regulatory procedures and changes.- May direct interaction with regulatory agencies on defined matters.Required Qualifications- Bachelor's Degree in Biomedical Engineering- Ideally 3-4 years of medical device background/experience in related field e.g. Regulatory Affairs, Quality Assurance, Service, Installation, Engineering- Experience of working and communicating with different regulatory authorities’ requirements in the Middle East (e.g. SFDA in Saudi Arabia, MoH in UAE, etc) and corresponding successful relationship management with the regulators preferred.- Ability, competence, and confidence to interact with people. Must be mature and tactful.- Effective interpersonal and communication skills.- Basic knowledge about standards and government regulations applicable to medical devices inside and outside the Middle East e.g. ISO 13485, 21 CFR 820 QSR, MDR, MDS-G5- Must be Saudi citizen according to SFDA regulation in the Saudi Arabia
Experience Level with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.
Typical Education and Experience: Bachelor’s degree (or equivalent experience) and 8 years of related experience or Master’s Degree with 6 years of related experience.
LI-OSI
Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.
Fighting cancer calls for big ideas.
We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.
TogetherWeFight