Regulatory Affairs Associate, Medical Devices
Stanbio Laboratory, an EKF Diagnostics Company
Stanbio Laboratory, an EKF Diagnostics Company, is looking for a Regulatory Affairs specialist situated in Boerne, Texas. The role involves ensuring compliance with relevant regulations, managing submissions, and collaborating with various departments to implement effective regulatory strategies. Ideal candidates should have a High School Diploma and at least two years of regulatory experience in the medical device field. Knowledge of ISO standards and strong organizational skills are essential to succeed in this fast-paced environment. #J-18808-Ljbffr Stanbio Laboratory, an EKF Diagnostics Company
- Ekf-Diagnostic in Boerne, Texas is seeking a Regulatory Affairs professional to ensure compliance with regulations for medical devices. You will assist in preparing regulatory submissions, maintaining registrations, and collaborating with multiple departments to uphold...Medical device
- ...preparation, compilation, and review of regulatory submissions and related regulatory... ...external standards. Assist Regulatory Affairs department in preparing and submitting... ...Provide assistance with product vigilance/medical device adverse event reporting activities to include...Medical deviceFull time
- ...Diagnostics USA (Stanbio Laboratory) in Boerne, Texas seeks a Quality Associate II to support the development and improvement of their... ...field and at least three years of quality experience in medical devices. Strong understanding of ISO 13485, ISO 9001, and related regulations...Medical device
- Ekf-Diagnostic is hiring a Quality Associate II in Boerne, Texas, to support the development and maintenance of the Quality Management... ...-related field and three years of quality experience in medical devices. Proficiency in Microsoft Office is essential. The position offers...Medical deviceWork at office
- ...SUMMARY OF POSITION: The Quality Associate II – Quality Management System (QMS) supports... ...handling activities, escalate to Regulatory as needed. Perform quality review of... ...of quality experience in relation to medical devices or In vitro diagnostics devices. Strong...Medical deviceWork at office
- ..., ISO 13485, GMP, and other applicable regulatory or customer standards. Champion a quality... ...Assurance, Quality Control, Regulatory Affairs, Finance, and IT. Adhere to current... ...within regulated manufacturing (medical devices, diagnostics, biotech). Demonstrated...Medical deviceFull timeContract workWork at office
- ...national origin, disability status, protected veteran status or any other characteristic protected by law. Description Day Medical Equipment Delivery Driver Rental Operations - Boerne, TX Schedule: Monday- Friday, 8:30 AM- 5:00 PM Compensation: About...Hourly payFull timeTemporary workLocal areaMonday to Friday
- ...OEM customers, as applicable. Support audits conducted by regulatory agencies. Develop and maintain performance of site Quality... ...experience. Two (2) years quality experience in relation to medical device or In vitro diagnostics devices. Two (2) years of...Medical deviceLocal area
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