In this role, you will be assisting RA activities WW for all administration system devices and
responsible for supporting RA global for any related activities.
Essential Duties and Responsibilities:
•Maintain Post Marketing activities (PMS, CER, PMCF, PSUR)
•Responsible EUDAMED responsibilities (DoC per batch record, public information review)
•Assist regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance for submission to Health Authorities [DMFs, MAFs, 510(k)s], customer requests, etc.] in compliance with regulations, guidelines and procedures.
•Provide regulatory expertise and operational direction to internal, and external customers to ensure conformance and compliance with corporate requirements, government regulations, guidelines and industry standards.
•Work closely with RA department to successfully achieve cross functional departmental objectives.
•Provide regulatory representation on project steering teams, as necessary.
•Review technical project documentation, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
•Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.
•Evaluation of a complaint to MDR / Vigilance: approval of the evaluation of a complaint after its implementation by the person responsible for complaints of quality assurance.
•Working with WEST internal/external representative
•Other duties as assigned
•Labelling Review, IFU and all commercial documentation/site, per relevant regulatory requirements
•Working with EU representative/Virtual manufacturer/ other representatives in the world
•Evaluation of a complaint to MDR / Vigilance: evaluation of a complaint after its implementation by the person responsible for complaints of quality assurance.
•Approval every DoC per Lot.
- תמיכה בתהליכי איסוף ואנליזה של נתונים של מוצר שנמצא בשוק (PSUR, PMS, CER, PSUR)
- תמיכה בהכנת תיקי רישום
- תמיכה בניהול מימסד נתונים מול הרשויות השונות
- עבודה מול גורמי ממשק שונים בחברה בארץ ובעולם
- חקירת תלונות והערכת סיכונים
•Education: Bachelor’s or master’s related discipline.
•Experience: Bachelor’s or master’s degree with 1-3 years’ experience in regulatory/pharmaceutical experience.
Preferred Knowledge, languages, Skills and Abilities:
•Strong technical skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
•Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
•Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
•Experience in Regulatory Affairs projects
קו"ח דרך הלינק המצורף, או למייל: