Sr. Regulatory Science Technician (Neurovascular) - Impact Business Group
Fremont, CA
About the Job
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.
Contract positions
Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
Permanent placed employees
Paid by and qualify for benefits in accordance with the policies of the hiring company.
Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
Internal Positions
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