Job Title: Regulatory Specialist or Manager (MDR)

　　Location: Irvine, CA – 100% Onsite

　　Type: Direct Hire/Permanent

　　Compensation: $110-145k salary (dependent on experience)

　　MUST have experience with electrical-mechanical medical devices.

　　Job Description:

　　Work with a team to interface with domestic or international regulatory agencies regarding applications, audits, reports, or correspondences in a timely, accurate, and comprehensive manner.

　　Interact with teams to provide regulatory guidance regarding the design, development, evaluation, labelling, and marketing of products.

　　Maintain current knowledge of relevant regulations and monitor emerging trends regarding industry regulations to determine potential impacts.

　　Support the improvement of the Company’s quality system, and work in conjunction with the company employees to ensure ISO 13485, MDSAP, and FDA QSR compliance for devices, including combinations products, as applicable.

　　Support implementation and maintenance of Quality Management Systems (QMS), strategy, framework, methodology, infrastructure, and activities to ensure compliance with regulations, including post marketing activities such as complaints, Recalls, NCRs, CAPAs, etc.

　　Collaborate with internal and external partners (e.g. laboratories, test agencies, manufacturers, packagers) to provide products that meet quality requirements for new and existing products.

　　Support Design Controls, Risk Management, Design Verification and Validation activities for new products and product modifications. Provide statistical technique and sample size guidance.

　　Obtain and maintain the latest regulatory guidance, standards, and requirements.

　　Participate in the test and clinical protocol development and assist clinical studies

　　Qualifications:

　　BS, or MS degree in regulatory, biomedical engineering or related field.

　　Compliance experience in quality assurance and regulatory affairs functions within the medical device, combination product, and biotechnology field or related industry.

　　3-10 years of experience in FDA Quality System Regulatory, ISO 13485, European Medical Device Regulatory (MDR), and MDSAP requirements; CE Mark (MDR) application, FDA 510(k), and other regulatory agencies’ approval process.

　　CQE, CQA, or other similar certification preferred.

　　Having regulatory and QA experience of electrical-mechanical medical devices. Having experience in therapeutic respiratory devices, e.g. humidifier, oxygen concentrator, ventilator, nebulizer, high flow oxygen therapy system, etc., is a plus.

　　Production quality control (QC) experience is a plus.

　　Global regulatory experience for active devices (devices with electronic components).

　　Experience with consumables as part of medical devices, and redesigning consumables

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.