Regulatory Affairs and Quality Control Specialist

2 weeks ago


Los Angeles, California, United States SprintRay Inc. Full time

Company Overview:
SprintRay Inc. is a dynamic organization committed to innovation and excellence in the realm of 3D printing technology. We foster a collaborative environment where creative minds come together to tackle complex challenges.

Position Summary:
We are currently in search of a dedicated Regulatory Affairs and Quality Assurance Specialist to join our team. This role is crucial in upholding our regulatory and quality standards while supporting our rapid growth.

Key Responsibilities:
- Provide regulatory and quality assurance support to ensure adherence to ISO 13485, MDSAP, and FDA QSR across all products.
- Develop and sustain the Company’s Quality Management System.
- Adhere to regulatory guidelines to guarantee that standards and requirements are consistently fulfilled.
- Stay informed about the latest regulations impacting medical device manufacturing.
- Assist the regulatory affairs and quality assurance team with submissions and documentation.

Qualifications:
- Minimum of 3 years of experience in regulatory compliance and quality assurance.
- Prior experience in the medical device sector.
- Familiarity with roles related to regulatory affairs and quality assurance.
- Experience in implementing a Quality Management System.
- Strong understanding of ISO 13485, MDSAP, and FDA QSR compliance.
- Knowledge of regulatory affairs principles.
- Bachelor’s degree in Chemical or Biomedical Engineering or a related discipline.
- Highly organized with a keen attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work collaboratively as part of a team and independently.

Compensation:
The salary range for this position is $78,000 to $142,560, reflecting a variety of factors unique to each candidate, including location, skills, education, experience, and performance.

Join Us:
If you are a proactive problem solver eager to influence the future of manufacturing, we invite you to explore opportunities with SprintRay Inc. Together, we can redefine the landscape of 3D printing and empower the next generation of innovators.



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