Sr. Regulatory Science Technician (Neurovascular) - iMPact Business Group

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Regulatory Science Technician (Neurovascular) for a 24 month + Contract/Contract to Hire opportunity.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. 

Assists in developing and validating testing methodology used to control raw materials, production intermediates and final products.  

Key Responsibilities:

• Assisting in developing and validating testing methodology used to control raw materials, production intermediates and final products.
• Helping establish, validating and documenting new or existing compound identification methods.
• Conducting testing of analytical samples for the laboratory area, the separation and characterization of protein drug candidates, formulation development, peptide mapping and other analytical methods of development.
• Conducting work in compliance with cGMP, safety and regulatory requirements.
• Providing analysis and evaluation of material and products at all stages of development process
• Understanding and operating FTIR spectroscopy, inductively coupled plasma mass spectrometry (ICP-MS), X-ray fluorescence (XRF), and UV-Vi's spectroscopy and will also employ gravimetric analysis.
• Additional analytical chemistry tests may be conducted based on the needs of the business.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field (or equivalent experience).
• 3+ years of experience in regulatory affairs, quality assurance, or a related field in the medical device or healthcare industry.
• Strong understanding of FDA, ISO, and other applicable regulatory requirements for medical devices.
• Excellent attention to detail, organizational skills, and the ability to manage multiple projects.
• Ability to work both independently and collaboratively within a team.
• Proficient in MS Office Suite; experience with electronic document management systems is a plus.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field (or equivalent experience).
• 3+ years of experience in regulatory affairs, quality assurance, or a related field in the medical device or healthcare industry.
• Strong understanding of FDA, ISO, and other applicable regulatory requirements for medical devices.
• Excellent attention to detail, organizational skills, and the ability to manage multiple projects.
• Ability to work both independently and collaboratively within a team.
• Proficient in MS Office Suite; experience with electronic document management systems is a plus.