IVD Regulatory & Quality Compliance Specialist
CorDx
A multinational biotech organization is seeking a Regulatory & Compliance Specialist in San Diego. The role involves ensuring compliance with IVD product regulations, supporting product development, and managing documentation. Candidates should have a Bachelor's degree and 3+ years in regulatory affairs. Strong communication and analytical skills are essential. The position offers a comprehensive benefits package, including medical insurance and retirement plans. #J-18808-Ljbffr CorDx
- ...Friday, 8:00AM - 4:30PM. Job Summary Under the direction of the Quality and Compliance Manager, the Quality and Compliance Specialist is responsible for ensuring that the healthcare organization meets all regulatory and accreditation standards. This role involves developing,...RegulatoryFull timeContract workTemporary workLocal areaMonday to FridayFlexible hours
- Dexcom is seeking a Quality Compliance professional in San Diego, California, to uphold the company’s standards in continuous glucose monitoring... ...with ISO 13485 and the ability to manage documents under regulatory timelines. Dexcom offers a flexible workplace and...RegulatoryRemote jobFlexible hours
- St. Paul's Senior Services is seeking a Quality and Compliance Specialist in San Diego, California. This temporary full-time role under the Quality... ...Manager ensures that the organization meets all regulatory standards. The specialist develops and implements quality...RegulatoryFull timeTemporary workFlexible hours
$120k - $150k
...strong. Overview The Senior Quality Systems (QS) Specialist II is responsible for... ...GMP, FDA, ISO, and global regulatory requirements. This role serves... ...system processes, leads compliance improvement initiatives, mentors... ...in the medical device, IVD or other regulated...RegulatoryWork at officeWorldwide$120k - $150k
...Position Summary: The Senior Quality Systems (QS) Specialist II is responsible for... ...GMP, FDA, ISO, and global regulatory requirements. This role serves... ...system processes, leads compliance improvement initiatives, mentors... ...in the medical device, IVD or other regulated...RegulatoryWork at office$90k - $95k
...healthcare. Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary... ...Position Summary: The Quality and Regulatory Compliance Specialist... ...processes for all in vitro diagnostic (IVD) products comply with applicable regulatory...RegulatoryFull time- Dexcom Inc. is seeking a skilled quality management professional in San Diego, California. This role involves managing quality systems compliance, drafting regulatory documents, and supporting audits. The candidate should excel in technical writing and possess a strong...Regulatory
$135k - $165k
Werfen seeks a Staff Quality Engineer in San Diego to ensure the safety... ...and efficacy of innovative IVD and medical device products.... ...significant experience in compliance and quality management. Responsibilities... ...life cycles, supporting regulatory audits, and collaborating...Regulatory$24 - $45.5 per hour
...Job Title: Quality Systems Specialist Job Description This role supports Quality Assurance operations in a GMP-regulated pharmaceutical... ...batch disposition and release activities, and ensures compliance with regulatory standards. The position offers exposure to the full quality...RegulatoryContract workTemporary work$85.12k - $95.76k
...Summary of Objective The Sr. Compliance Specialist supports the execution and maintenance of site... ...programs to ensure adherence to applicable regulatory requirements and company policies... ...effectiveness tracking, and supports Quality Management System (QMS) activities including...RegulatoryFlexible hoursWeekend work$70k - $82k
...sampling strategies aligned with risk and compliance priorities. Document findings clearly;... ...activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). Perform... ..., Supply Chain, and IT to strengthen quality systems. Maintain audit schedules, metrics...RegulatoryFull time- ...patients and families who need them most. The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data... ...data, and documentation meet cGMP requirements and regulatory expectations for clinical and commercial...RegulatoryWork at officeShift work
$105.8k - $132.25k
...San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs... ...responsible for ensuring regulatory compliance and supporting global... ...for in vitro diagnostic (IVD) products. It involves... ...input to, and approve various quality management system related documents...RegulatoryFull timeWork at officeLocal area$71k - $104.6k
...Inc. is seeking a Post-Market QA Specialist to play a key role in ensuring safety and compliance of molecular diagnostic... ...investigations, and supporting regulatory reporting. The ideal candidate... ...a B.S. degree and 3+ years in quality roles within an ISO environment...Regulatory- Artiva Biotherapeutics Inc., based in San Diego, California, is looking for a Quality Assurance Compliance professional. This role is focused on supporting deviations, CAPAs, and change control processes critical for ensuring compliance in a regulated industry. The ideal...
- Quality Specialist - Product Complaints San Diego, CA, United States The Post-Market QA Specialist... ...the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular... ...development and/or manufacturing of IVD or other medical device products preferred...Regulatory
$117.5k - $176.3k
...of the best work of your career. Sector Quality Auditors They are a catalyst for building a world-class quality culture where compliance is seamless, processes are intelligent,... ...knowledge of AS9100, AS9145, AS9102 and other regulatory compliance requirements Demonstrated...RegulatoryFull timeRelocationShift work$85k - $105k
...for rare patients.Position Summary:The Quality Associate supports Quality Operations through... ...Readiness Action Items and provides compliance support for the quality systems at Travere... ...for internal, external, mock, and regulatory auditsProvide quality and compliance oversight...RegulatoryContract workTemporary workShift work- ...delivery and vaccinology. The Corporate Compliance Officer is responsible for leading,... ...reporting requirements, document retention, quality compliance, anti‑corruption, data privacy... ...Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities...Regulatory
$30 - $33 per hour
We’re looking for a Senior Quality Assurance Associate who enjoys being close to the product... ...our finished goods meet quality, regulatory, and customer expectations—while also supporting... ...priorities while keeping quality, compliance, and continuous improvement top of mind....RegulatoryHourly payLocal area$85k - $89k
Quality Assurance Specialist II - San Diego By Catalent, Inc., a leading global contract development and manufacturing organization (CDMO... ...Summary Supports clinical trial projects by ensuring compliance with regulatory requirements, good manufacturing practices (cGMP),...RegulatoryContract work$25 - $31 per hour
Job Title: Quality Assurance Specialist Salary Range: $25-31 Reports To: Quality Assurance Director... ...works with the Quality Improvement, Compliance and Risk Departments to plan, organize... ...systems to ensure compliance with regulatory requirements, standards, and company...RegulatoryRemote workShift work- ...need them most. Position Summary The Quality Control Associate, Raw Materials is... ...materials meet established specifications, regulatory requirements, and GMP standards. As... ...verifying material identity, quality, and compliance, the team enables reliable production...RegulatoryWork at office
- ...Wellness Program Job Summary: The Gateway Quality Analyst Specialist plays a critical role in driving... ...team performance, enforcing compliance standards, and transforming raw operational... ...policies, SOPs, and applicable regulatory requirements Audit user activity and...RegulatoryTemporary workWork experience placement
- ...QUALITY SYSTEMS & DOCUMENTATION SPECIALIST Looking to join a cutting edge medical device team paving the way in a very unique product... ..., manufactured, and supported in full compliance with FDA, ISO 13485, and global regulatory expectations. You’ll own the systems, processes...RegulatoryLocal areaImmediate start
- ...Job Description The Compliance Specialist is responsible for reviewing mortgage loan files that... ...accuracy, timing, fees, and loan data for regulatory compliance Document findings,... ...issues as appropriate Support audits, quality control reviews, and regulatory...RegulatoryRemote work
$90k - $110k
Werfen North America is seeking a Quality Systems Specialist III in San Diego, CA to enhance the Quality Management System (QMS) and ensure compliance with applicable regulations. This temporary role involves responsibilities around CAPA processes, internal audits, and...Temporary work- ...Operations (ClinOps) on clinical process compliance, continuous improvement, and inspection... ...ongoing knowledge of applicable regulatory requirements and business standards Perform... ...related biopharma roles; Clinical Trial Specialist/Clinical Research Coordinator experience...Regulatory
$75k - $90k
SEC Compliance & Corporate Governance Specialist Country: United States Overview As our SEC Compliance & Corporate... ...in keeping our governance and regulatory processes running smoothly and thoughtfully... ...litigation claims; liaises with Quality, R&D, Marketing and Sales...RegulatoryContract workWork at officeLocal areaWork from home- ...Full time Job Title: Associate Regulatory Affairs Manager Location:... ...documents for medical device and IVD products. This role will... ...regulatory projects, ensuring compliance with FDA, ISO 13485, and other... ...mentorship to junior staff or specialists on assigned projects. Education...RegulatoryFull timeWork at officeFlexible hours
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