What are the responsibilities and job description for the Regulatory Science Specialist position at Rose International?
Required Education :
B.S. degree in Biological Sciences or related field
Required Qualifications / Skills / Experience :
Minimum of 5 years of Quality Assurance and / or Sterility Assurance experience
Knowledge of cGMP / cGDP required
Knowledge of medical devices, concepts of manufacturing equipment, and / or sterilization
Efficient computer skills with basic knowledge of Microsoft Office (i.e. Word / PowerPoint / Excel / Outlook / Teams)
Must have effective verbal and written communication skills
Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision
Position Overview :
Support manufacturing of orthopedic medical device products pertaining to the sterilization and cleanliness of the devices. Assess the impact of manufacturing related changes on the sterilization and cleanliness attributes of finished medical device products. Familiar with cGMP / cGDP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA). Knowledgeable in scientific concepts, measures, and terminology. Able to understand and apply specific laboratory protocols. Performs QA / QC duties as required.
Responsibilities :
Author and execute protocols and final reports to assess impact of manufacturing related changes against cleanliness requirements for impacted medical devices
May provide analysis and evaluation of materials and products at all stages of development process
Help manage the execution microbiological and chemistry testing both internally and externally
Communicate and collaborate with project owners to obtain all necessary information for assessment
May entail communication with internal operations and / or external suppliers
Conducts work in compliance with cGMP / cGDP, safety and regulatory requirements
Industry :
Medical Technology
Estimated Start Date :
3 / 24 / 2025
Only those lawfully authorized to work in the designated country associated with the position will be considered.
Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.
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