Regulatory Affairs Manager, Medical Devices
CorDx
CorDx in San Diego is looking for a Regulatory Affairs Manager to oversee the preparation and submission of regulatory documentation for medical devices. The successful candidate will ensure compliance with FDA regulations and ISO 13485, while collaborating with cross-functional teams. Required qualifications include a Bachelor's degree in a relevant field and 5-7 years of regulatory experience in the medical device industry. The role offers a competitive compensation package and comprehensive benefits including medical and dental insurance. #J-18808-Ljbffr CorDx
- ...countries, CorDx delivers rapid testing and point‑of‑care medical device solutions used in the detection of infectious disease... ...questions in healthcare. Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary The Regulatory...Medical deviceFull timeFlexible hours
- ...The Director of Regulatory Affairs will be based in San Diego, CA. The role includes but is not limited to the development... ...relevant work experience, preferably within the Medical Device industry Minimum 5 years of managing a regulatory team Experience working with...Medical deviceWork experience placementWork at office
- elemed is seeking a Director of Regulatory Affairs based in San Diego, CA. This pivotal role... ...strategies for product submissions, managing registrations, and overseeing team development... ...least 10 years of experience in the Medical Device industry and at least 5 years in a...Medical device
- ...Senior Regulatory Affairs Manager CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global... ..., CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such...Medical deviceFull time
$135.1k - $225.1k
...forever change how diabetes is managed. To unlock information and... ...with commercial, medical/clinical, regulatory, legal, and HR teams to uphold... ...function within the medical device or pharmaceutical industries... ...commercial operations, medical affairs, and other cross‑functional...Medical deviceWork at officeHome officeFlexible hours- Position: Senior Program Project Manager (Exp in Regulatory or Medical Device Industry) Location: San Diego, CA Duration: 6 Months Total Hours/week: 4... ...especially Quality, Compliance Engineering and Regulatory Affairs. Accountable for developing project budget including...Medical deviceContract workDay shift
$210k - $240k
Senior Director, Regulatory Affairs-CA Requisition ID: 1032 Salary Range:... ...product updates Author and manage IDE, PMA, and PMA supplement... ...regulatory strategy for complex BCI devices, including AI/ML... ...software‑ and firmware‑driven medical technologies Ensure ongoing...Medical deviceFull timeFlexible hours- ...Associate Regulatory Affairs Manager CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in... ...countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease...Medical deviceFull time
$181k - $288k
...Director, Quality & Regulatory- Mergers & Acquisitions (M&A) The... ...post-close. The Director also manages quality and regulatory risks... ...Partner with Regulatory Affairs, Legal, and external authorities... ...in FDA regulated global medical device environments (Class III products...Medical deviceFull timeWork at officeWork visaRelocation package3 days per week- ...Engineer II in San Diego, CA for a contract position lasting 12 months. This role involves supporting validation processes in a medical devices company and requires a solid understanding of ISO 13485 regulations. The ideal candidate will have at least 3-5 years of...Medical deviceContract work
$95k - $125k
...critical role, you will establish and maintain supplier quality management processes, working towards closing significant quality gaps.... ...in quality roles, preferably in regulated environments like medical devices. The annual salary range is $95,000 - $125,000, with a...Medical device- MillenniumSoft Inc is seeking a Senior Electrical Engineer for a 12-month contract in San Diego, CA. The role involves designing and developing components and systems, demonstrating advanced knowledge in engineering practices and product development. The ideal candidate...Medical deviceContract work
- MillenniumSoft Inc is looking for a Sr. Quality Engineer based in San Diego, CA. This role requires expertise in risk management and quality assurance for medical devices. The ideal candidate should have a Bachelor's degree in Science and at least 9 years of relevant experience....Medical deviceContract work
- ...12-month contract position. The engineer will leverage their expertise in product development to manage verification and traceability of requirements for medical devices. Ideal candidates will have a bachelor's degree and at least 5 years of experience in Systems Engineering...Medical deviceContract work
- Bioventus is seeking a Senior Territory Manager for Peripheral Nerve Stimulation in San Diego, California. In this role, you will... ...of experience in sales, preferably in the neuromodulation or medical device industry. Join an inclusive team committed to excellence and...Medical device
- ...A BS in Mechanical Engineering with at least 3 years of experience is required, alongside strong communication skills. Experience in the medical device sector is preferred. This role is contracted for 12+ months with full-time hours. #J-18808-Ljbffr MillenniumSoft IncMedical deviceFull time
- ...documentation and processes across the organization. You will lead design controls with R&D, clinical, and operations, drive CAPA and change control activities, and support audits and inspections for a medical device manufacturing environment. #J-18808-Ljbffr BioTalentMedical device
- ...Inc is seeking a Senior Quality Engineer specializing in Risk Management to join their team in San Diego, CA. This role involves... ...risk management activities across product lifecycles in the medical devices sector, ensuring compliance with standards. The ideal candidate...Medical device
- ResMed Inc. seeks a Quality Auditor in San Diego, CA to ensure compliance with regulatory standards in the medical device industry. You will manage audits, compliance reports, and support quality projects while communicating with various stakeholders. The ideal candidate...Medical device
- A leading medical technology company is seeking a Security Engineer to enhance security in their products and services. This hybrid position... ...cybersecurity. The position is based in San Diego, CA, fostering innovative solutions for medical devices. #J-18808-Ljbffr BioTalentMedical device
- ...staffing firm is seeking a Staff Electrical Engineer to provide comprehensive engineering support in the design and development of medical devices. Responsibilities include designing manufacturable products, ensuring quality, and leading cross-functional project teams....Medical deviceHourly payContract work
- MillenniumSoft Inc is hiring for a contract role in San Diego, California, focusing on risk management for medical devices. The position involves ensuring compliance with ISO standards and requires strong cross-functional collaboration. The ideal candidate typically has...Medical deviceContract work
- ...III in San Diego, CA to support the conversion from ISO 9001:2015 to ISO 13485:2016. The role requires a minimum of 2 years of medical device experience and expertise in risk assessment. The ideal candidate will communicate effectively with subject matter experts and revise...Medical devicePart timeFlexible hours
- A global medical technology company based in San Diego seeks a Mechanical Engineer to join a cross-functional team. This role involves designing and developing sustainable products, applying advanced engineering principles, and leading other engineers. Candidates should...Medical device
- ...requires mid-level experience in electrical engineering, proficiency with oscilloscopes, and troubleshooting skills, ideally within medical devices. The role involves building, testing, and troubleshooting electronic circuitry, working with various laboratory test equipment,...Medical device
- Med Device QA is looking for a skilled Manufacturing Engineer with over 6 years of experience, especially in the medical device industry. The ideal candidate will have proven capabilities in supporting the manufacturing of electronic medical devices and strong experience...Medical device
- A leading medical devices company in San Diego is seeking a Senior Staff Quality Engineer to lead projects aimed at improving quality compliance in the dispensing implementation process. The ideal candidate will have a Bachelor's degree in engineering and at least 10 years...Medical deviceContract work
$50 - $75 per hour
Quality Engineer (Medical Device is a MUST) San Diego, CA , $50-$75/hr Looking for a contract role where you can drive quality, validation... ...evaluation Perform statistical analysis and support risk management, audits, and cross‑functional quality initiatives What does...Medical deviceHourly payContract work- ...control processes. Candidates must have a BS in engineering and minimum 5 years of experience, preferably in high volume disposable medical devices. The position allows for flexible work hours but expects availability for meetings during standard times. Responsibilities...Medical deviceRemote jobContract workFlexible hours
$115k - $125k
...processes. Principal Accountabilities Provide technical support to manage change and troubleshoot problems, coaching other engineers on... ...used in production and validate such equipment using standard medical device industry techniques. Work with the NPI engineering group to...Medical deviceWork at officeLocal area
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