Medical Device Regulatory & Quality Specialist
SprintRay Inc.
SprintRay Inc. in Huntington Beach, CA is hiring a Regulatory Affairs & Quality Associate to ensure global regulatory and quality compliance for our medical device portfolio. The role demands a proactive, detail-oriented professional with experience navigating regulatory landscapes, contributing to PMS, CERs, PMCF, PSURs, and audits, while working closely with Quality, R&D, Engineering, and Manufacturing teams. #J-18808-Ljbffr SprintRay Inc.
- Regulatory Affairs & Quality Associate Location: Huntington Beach, CA Compensation: $80,000 - $95,000k (Depending on experience) About the Role... ...mission is to deliver safe, reliable, and innovative medical devices that improve patient outcomes. We are seeking a highly motivated...Medical deviceFull timeWork at office
$120k - $155k
Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA... ...a Regulatory Affairs Specialist, you will develop and... ...Collaborate with clinical, quality, and R&D teams to... ...pharmaceutical or medical device industry Direct...Medical deviceLocal areaFlexible hours- ...Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project... ...and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability... ...preferred). Strong knowledge of FDA Quality System Regulations, including but not...Medical device
- ...This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of... ...collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for...Medical deviceWork at office
$110.1k - $183.4k
...Flexibility: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this... ...needs and project efficiencies.Review quality, preclinical, clinical, and... ...regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related...Medical deviceFull timeFor contractorsLocal area$92k - $138k
...developing innovative medical technologies that improve... ...conditions. The Regulatory Affairs organization partners... ...product development, quality, labeling, clinical,... ...Regulatory Affairs Specialist serves as a regulatory... ...initiatives.Coordinate Unique Device Identification (UDI)...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours$80k - $100k
...Regulatory Affairs SpecialistBring more to life.Are you... ...life.Masimo is a global medical technology company... ...The Regulatory Affairs Specialist is responsible for obtaining... ...of medical device regulations to help effective... ...for medical device.Quality Systems per ISO 13485....Medical deviceWork experience placementWorldwide$80k - $95k
...positions become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and... ...support the company’s worldwide medical device business. This position supports... ...approvals and shipping authorizations to Quality Assurance and other appropriate...Medical deviceWork at officeWorldwideWeekend workAfternoon shift- ...information to project teams and management. Develop and implement regulatory strategies and processes to ensure timely global... ...10k/PMA submissions and US assessments for class II and III medical devices. Develop Technical Documentations and EU assessments. Conduct...Medical deviceLocal areaWorldwide
$125k - $130k
...collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the... ..., come and join us! About This Opportunity - Senior Regulatory Affairs Specialist On this role, the Senior Regulatory Affairs Specialist...Medical deviceWork at office- Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to... ...design control deliverables. Prepare Quality Assurance/Regulatory reports and present... .... Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/...Medical deviceImmediate start
- The Kardion Regulatory Affairs team is seeking a high energy, driven... ...Regulatory Affairs Specialist is a senior technical expert... ...for Class III cardiovascular medical devices. In this highly visible role... ...functional teams including R&D, Quality, Clinical, and Marketing, providing...Medical deviceFull timeContract workRemote work3 days per week
- Company & Job Overview Diality is a medical device company focused on developing solutions... ...care setting. The Principal Regulatory Affairs Specialist will serve as a key contributor responsible... ..., consistently delivers high-quality work products, and drives activities...Medical deviceWork at office
$89.2k
...we continually advance the quality of patient care with innovative... ...individual for a Senior Regulatory Affairs Specialist position (hybrid work mode)... ...growing active implantable device portfolio. This role will... ...Regulatory Affairsexperience in the medical industry Prior experience...Medical deviceHourly payWork at officeLocal areaRelocationShift work3 days per week$28 - $34 per hour
A medical technology company based in Huntington Beach, CA is seeking a hands-on individual to assemble, test, and package medical devices. Candidates should have prior experience in manufacturing, exceptional... ...and a commitment to safety and quality. This role offers competitive...Medical deviceHourly payFull time$28 - $34 per hour
Hands‑on role assembling, testing and packaging medical devices, based onsite in Huntington Beach, CA. Pay $28‑34/hr depending on experience... ...medical devices using detailed work instructions. Quality & Regulatory Compliance: Work in compliance with FDA 21 CFR Part 820,...Medical deviceHourly payFull timeImmediate startShift work- ...) from development to validated production. The role demands hands-on ownership of IQ/OQ/PQ/PPQ, pFMEA, and test method validation, with strong ISO 13485 and FDA QSR familiarity; direct experience with Class III medical devices is required. #J-18808-Ljbffr BiVACOR Inc.Medical device
$155k - $169.99k
BiVACOR in Huntington Beach is seeking a Senior Manager for Quality Engineering to lead their quality organization in developing a... ...is a high-impact role requiring extensive experience in the medical device sector, particularly with Class III Active Implantable Medical...Medical device$110k - $145k
Qnovia, Inc. is seeking a Quality Assurance Engineer to develop and maintain quality management... ...pivotal in advancing products through regulatory approval to commercial production.... ...of quality assurance experience in medical device manufacturing. The position offers a salary...Medical device- ...You will be the on-site technical authority, collaborating with surgical teams, ICU staff, and biomedical engineers to ensure safe device operation from implant through follow-up. Responsibilities include on-site clinical and technical support, pre‑implant checks, intraoperative...Medical device
$130k - $180k
...united by purpose, working on something truly unprecedented. Every device you support, every team you train, and every urgent call you... ..., field-based engineering role at the frontier of Class III medical device technology, where your expertise will directly support patients...Medical deviceRelocation packageFlexible hoursDay shift- ...improvement of manufacturing processes for the Total Artificial Heart, aiming for high quality and efficiency. With at least 8 years of experience in engineering and a background in medical device regulations, you will also mentor junior engineers and manage cross-functional...Medical device
$90k - $120k
...Description Job Description Regulatory Labeling and Documentation Specialist Location: Huntington Beach, CA... ...innovating while maintaining the highest quality standards for our products and... ...safe, reliable, and innovative medical devices to improve patient outcomes....Medical deviceFull timeWork experience placementLocal area- Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy... ...and approval of manufacturing changes for Class IIb (EU) medical devices. Qualifications: Experience supporting new device...Medical device
- ...to support depot operations and help advance careers in the medical device industry. You will receive decommissioned units, perform cleaning... ..., and paperwork, and ensure proper shipping with BOM and quality documents. PPE is required, training is provided and paid, and...Medical device
$40 - $46 per hour
Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated, IT Industries This is an exciting... ...a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to present KPIs in...Medical deviceHourly pay- ...manufacturing yield and productivity goals; Assist manufacturing/process/R&D engineers in resolving product and process problems; Complete documentation such as Device History Records per GDP and GMP requirements; Support introduction of new products onto the manufacturing lineMedical device
- Aerotek - JobID: JP-005852020 [Production Operator / Assembly Line Worker] As an Assembler at Aerotek, you'll: Perform assembling, loading, and unloading of parts; Be involved in a fast-paced environment and many overtime opportunities; Perform other duties as assigned...Medical deviceImmediate startNight shift
$33.65 - $43 per hour
...Quality SpecialistJoin our team as a Quality Specialist, where you will ensure compliance with customer and internal quality requirements in a high-reliability... ...for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and...Contract workTemporary workWork at officeMonday to FridayDay shift$50 - $55 per hour
...Immediate need for a talented Quality Specialist. This is a 06 months contract opportunity with long-term potential and is located in... ...benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending...Contract workWork experience placementLocal areaImmediate start
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