Regulatory Affairs Specialist Los Angeles

At SprintRay, we are in a super-charged growth mode and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain the Company's Quality Management System and follow regulatory guidance to ensure standards and requirements are consistently met.Job Description:Provide RA-QA support to ensure compliance with ISO 13485, MDSAP, and FDA QSR for all products.Implement and maintain the Company's Quality Management System.Follow regulatory guidance to ensure standards and requirements are consistently met.Stay up to date with the new regulations for the medical device manufacturing companies.Help the RA-QA team in regulatory submissions.Requirements:3+ years of experience in regulatory compliance and QA.Previous experience in Medical Devices.Previous experience working in a RA-QA-related function.Previous experience with implementation of a Quality Management System.Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance.Understanding of Quality Management System.Knowledge and understanding of regulatory affairs.BS in Chemical or Biomedical Engineering or a related field.Extremely organized and detail-oriented.Excellent written and verbal communication skills in English.Team player, as well as being able to work independently.Target Salary Range:

$78,000-$142,560Actual compensation packages consider a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The estimate provided has not been adjusted for all of these factors. At SprintRay, it is not typical for an individual to be hired at or near the top of the range for their role. The total compensation package for a position may also include an annual performance bonus, medical/dental/vision benefits, and/or other applicable compensation.About SprintRay:SprintRay is a highly collaborative environment where innovative people have the freedom to satisfy their curiosity by finding creative solutions to hard problems. If you are a relentless problem solver who wants to shape the future of 3D printing, join SprintRay! Together, we can revolutionize the next 100 years of manufacturing and empower future generations of doctors, designers, and makers all over the world.

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