Regulatory Affairs Specialist — IVD Medical Devices
Grifols Shared Services North America, Inc
A global healthcare company is seeking a Regulatory Affairs Specialist III in San Diego, CA. The role involves ensuring regulatory compliance and supporting global market access for IVD products. Candidates must have a Bachelor's degree and at least 6 years of industry experience, including 4 years in Regulatory Affairs. The position offers a competitive salary and a variety of benefits, alongside opportunities for professional growth and career progression. #J-18808-Ljbffr Grifols Shared Services North America, Inc
$105.8k - $132.25k
...Regulatory Affairs Specialist III - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular Full-Time Area: TECHNICAL Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world...Medical deviceFull timeContract workWork at officeLocal area$73k - $114k
Hologic, Inc. is seeking a Regulatory Affairs Specialist to assist in managing regulatory activities for women's health technologies. This hybrid... ...ideal candidate should demonstrate strong knowledge of medical device regulations and excellent communication skills, ensuring...Medical device- ...Regulatory Affairs Specialist Marlborough, MA, United States San Diego, CA, United... ...innovative, compliant, and safe medical technologies to market,... ...including artificial intelligence devices Support new product... ...Technical Documentations for IVD medical devices to support...Medical deviceWork at officeLocal area3 days per week
- ...seeking a Sr. Program Manager to oversee project management in a medical device company in San Diego, CA. The role encompasses program... ...Bachelor’s degree in a technical field, significant experience in IVD product development, and excellent communication skills. This...Medical deviceRemote job
$90k - $95k
...testing and point-of-care medical device solutions used in the detection... ...: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San... ...all in vitro diagnostic (IVD) products comply with applicable... ..., Engineering, Regulatory Affairs, Quality Management) or...Medical deviceFull time- Argen Corporation in San Diego seeks a Regulatory Affairs Specialist to ensure compliance for regulated dental products. The role includes maintaining... ...assurance or regulatory experience, preferably in the medical device industry. Our benefits include medical plans, a 401k,...Medical device
- ...testing and point-of-care medical device solutions used in the detection... ...time Job Title: Associate Regulatory Affairs Manager Location: Onsite -... ...for medical device and IVD products. This role will assist... ...to junior staff or specialists on assigned projects. Education...Medical deviceFull timeWork at officeFlexible hours
- ...is seeking a Complaints Management Specialist based in San Diego, CA. The role focuses... ...managing complaints and ensuring regulatory compliance in the medical device industry. Ideal candidates have a background in QA or Regulatory affairs and possess strong communication...Medical deviceContract work
- ...Responsibilities Expertise in vitro diagnostic (IVD) products, cGMP FDA regulatory compliance, and industry guidance initiatives such as MDDAP Independently... ...but not required Experience 12+ years of Biotech / Medical Device / Pharmaceutical industry experience High volume...Medical deviceFlexible hours
$90k - $95k
...Regulatory & Compliance Specialist CorDx a multi-national biotech organization focused on pushing the limits... ...rapid testing and point-of-care medical device solutions used in the detection of infectious... ...for all in vitro diagnostic (IVD) products comply with applicable...Medical deviceFull time- ...Company: One of Our Clients Job Title: Regulatory Affairs Associate Duration: 12 Months (... ...and organizes registration packages for device products. Prepares registration packages... ...global dossiers Two to four years of medical device industry experience with regulatory...Medical deviceWork at officeWorldwideHome office
- ...professional to maintain and improve the quality system in accordance with MDSAP, ISO, FDA, QSR, and Argen policies. This role supports regulatory documentation for domestic and international product registrations and ensures compliance to applicable standards. You will...Medical device
- MillenniumSoft Inc is seeking a Specialist - Clinical Customer Advocacy in San Diego, CA... ...with both FDA and international regulatory requirements. Candidates should hold a... ...us to make a meaningful impact in the medical device industry. #J-18808-Ljbffr MillenniumSoft...Medical device
- ...Coordinator for a 9+ month contract position based in San Diego, CA. This role involves supporting compliance and documentation for a Medical Device Company. The ideal candidate will have strong project management skills and experience in managing documentation workflows....Medical deviceRemote jobContract work
- ...Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). Perform gap assessments... ...1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry. Working knowledge of FDA 21...Medical device
$100k - $130k
...management system, with a primary focus on IVD products and equipment. Conduct... ...alignment with industry best practices and regulatory requirements. Requirements... ...management principles and practices in the medical device industry. Excellent communication and...Medical device$90k - $150k
...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and...Medical deviceFull time- ...Senior Strategic Advisor / Business Development Executive – IVD & Diagnostics Position Overview Our client is seeking a Senior... ...professional with a background in healthcare distribution, diagnostics, medical devices, procurement, national accounts, or business development....Medical device
$129.6k - $207.4k
...is one of the largest global medical technology companies in the world... ...of In‑Vitro Diagnostic (IVD) products, including Research... ...collaborate closely with R&D, Regulatory Affairs, and Operations to implement... ...Engineering within the IVD or medical device industry. Strong experience...Medical deviceHourly payWorldwideShift work- ...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
...in engineering or applied science along with 5+ years of experience in quality roles, preferably in regulated environments like medical devices. The annual salary range is $95,000 - $125,000, with a comprehensive benefits package offered. #J-18808-Ljbffr Burke Porter,...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 Quality Control Inspector in San Diego, CA. This entry-level position involves executing testing in line with quality standards. Responsibilities include visual inspections, analyzing results, and ensuring compliance with regulations...Medical deviceContract work
- ...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. Responsibilities...Medical deviceContract work
- ...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
- ...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. Responsibilities include...Medical deviceContract work
- ...collaborating with sales and marketing. The ideal candidate has over 5 years of experience in sales, preferably in the neuromodulation or medical device industry. Join an inclusive team committed to excellence and diversity. Apply now to be part of a company focused on improving...Medical device
- ...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
- ...Management to join their team in San Diego, CA. This role involves leading risk management activities across product lifecycles in the medical devices sector, ensuring compliance with standards. The ideal candidate will have over 8 years of experience in a regulated industry,...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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist — IVD Medical Devices. Be the first to apply!
- legal compliance analyst San Diego, CA
- senior compliance analyst San Diego, CA
- regulatory compliance specialist San Diego, CA
- regulatory affairs consultant San Diego, CA
- regulatory affairs specialist San Diego, CA
- compliance coordinator San Diego, CA
- cybersecurity policy and compliance analyst San Diego, CA
- compliance specialist San Diego, CA
- senior regulatory affairs specialist San Diego, CA
- healthcare compliance officer San Diego, CA

