Regulatory Affairs Specialist - SprintRay
Huntington Beach, CA
About the Job
Location: On-Site
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
- Helping 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 Quality Management System
- Knowledge and understanding of regulatory affairs
- Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance
- BS in Chemical or Biomedical Engineering or a related field
- Extremely organized and detailed oriented
- Have great time management skills
- Have excellent written and verbal communication skills in English
- Be a team player, as well as being able to work independently
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.
To All Recruitment Agencies:
Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.
