Regulatory Affairs (RA) and Quality Assurance (QA) senior specialist

Regulatory Affairs (RA) and Quality Assurance (QA) senior specialist

Location: Huntington Beach

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) senior specialist to provide RA-QA support to ensure compliance with FDA QSR EU MDR ISO 13485 and MDSAP for all SprintRay medical devices as well as implement maintain and improve and the Companys 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 FDA QSR EU MDR and all applicable RoW (Rest of World) requirements for SprintRay medical devices.
• Implement maintain and improve the Companys Quality Management System (QMS).
• Stay up to date with the new regulations for the medical device manufacturers and provide regulatory input to minimize potential non-compliance.
• Research country specific regulatory requirements and provide support to strategic regulatory planning.
• Assist in global medical device submissions such as US EU Canada Brazil Australia Japan etc.
• Communicate and prepare responses to Regulatory Authorities and Notified Bodies within assigned timelines.
• Maintain and update regulatory files such as Technical Files product registrations release documents etc.
• Provide support to assess medical device reporting field actions and other post-market surveillance activities.
• Participate in internal and external audits.
• Assist other teams (i.e. R&D marketing etc.) for new product development projects.
• Implement maintain and improve the supplier qualifications.
• Assist the RA-QA in design control phases for medical devices.
• Assess monitor and document regulatory impact of engineering changes in various jurisdictions where the product is licensed.
• Assess and review product labels IFU and SDS for compliance with applicable regulations.
• Maintain product listings and unique device identifiers in country-specific databases.
• Provide support to management review meetings to ensure all quality standards and regulatory requirements are met.

Requirements:

• 5 years of experience in regulatory compliance and QA
• Previous experience in Medical Devices
• Previous experience with implementation of a Quality Management System
• Strong knowledge and understanding of ISO 13485 MDSAP EU MDR and FDA QSR compliance
• Strong understanding Quality Management System
• Strong knowledge and understanding of regulatory affairs
• BS in 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

SprintRay is an equal opportunity employer.

Salary Range: $95000 - $110000

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.