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
- ...strategies for product and processes meet regulatory and business objectives. This role is... ...to cross-functional stakeholders across Quality, Regulatory Affairs, Engineering, Operations... ...quality systems for product realization compliance with applicable regulations and...RegulatoryFull timeWork at officeWorldwideHome officeFlexible hours
$90k - $95k
...Regulatory & Compliance Specialist CorDx a multi-national biotech organization focused on pushing the limits... ...$95,000 Position Summary: The Quality and Regulatory Compliance Specialist... ...processes for all in vitro diagnostic (IVD) products comply with applicable...RegulatoryFull time$90k - $95k
...Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary... ...$95,000 Position Summary: The Quality and Regulatory Compliance Specialist... ...processes for all in vitro diagnostic (IVD) products comply with applicable...RegulatoryFull time$70k - $82k
...need them most. We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits... ...Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). ~ Perform gap...Regulatory$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,... ...experience in the medical device, IVD or other regulated...RegulatoryWork at office$40.92 - $46.04 per hour
...Sr. Compliance Associate I Our investment is in People who make an impact, drive progress... ...their skills to hosts customer and regulatory audits, assist in the execution of internal... ...personable and highly knowledgeable of the Quality Management System. Essential Duties...RegulatoryFull timeFlexible hours$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$85.12k - $95.76k
...Sr. Compliance Specialist The Sr. Compliance Specialist supports the execution and maintenance... ...programs to ensure adherence to applicable regulatory requirements and company policies... ...effectiveness tracking, and supports Quality Management System (QMS) activities including...RegulatoryFull timeFlexible hoursWeekend work$105.8k - $132.25k
...Regulatory Affairs Specialist III - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular Full-Time... ...responsible for ensuring regulatory compliance and supporting global market... ...regulatory input to, and approve various quality management system related...RegulatoryFull timeContract workWork at officeLocal area$95k - $105k
...Laboratories in San Diego is seeking a Regulatory Affairs Specialist III to oversee the preparation of... ...will have significant experience in IVD and be familiar with FDA and CE regulations... ...trials, and ensuring regulatory compliance. ACON offers a competitive salary package...Regulatory$105.8k - $132.25k
A global healthcare company is seeking a Regulatory Affairs Specialist III in San Diego, CA. This role focuses on ensuring regulatory compliance and global market access for in-vitro diagnostic (IVD) products. Candidates must have a Bachelor’s degree and at least 6 years...Regulatory- ...Complaint Compliance Specialist (Specialist 3) Be part of something bigger! BD is one of the... ...designed to ensure complaints conform to regulatory requirements and company policies and... ...when necessary Partners with other quality professionals to address complaint...RegulatoryWorldwide
$75k - $95k
...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 review... ..., and documentation meet cGMP requirements and regulatory expectations for clinical and commercial...RegulatoryWork at officeShift work$76.44k
Job Description CDM Smith is seeking a Quality Control (QC) Specialist to oversee and ensure the highest standards of quality, compliance, and performance on federal construction... ...construction activities meet contractual, regulatory, and technical requirements. This...RegulatoryContract workFor contractorsFor subcontractorH1bFlexible hours$135k - $165k
Werfen in San Diego is looking for a Staff Quality Engineer to ensure compliance and excellence in IVD and medical device products. In this individual-contributor... ...management systems, support audits, and ensure regulatory compliance. This role offers a competitive salary...Regulatory- ...This hybrid role involves planning and executing internal audits of GxP processes, leading supplier audits, and ensuring compliance with regulatory standards. The ideal candidate has a Bachelor’s degree in a scientific field and 1-2 years of auditing experience in biopharma...Regulatory
$117.5k - $176.3k
...best work of your career. The Sector Quality Auditors are a catalyst for building a?world-class quality culture where compliance is seamless, processes are intelligent,?and... ...of AS9100, AS9145, AS9102 and other regulatory compliance requirements? Demonstrated ability...RegulatoryFull timeRelocationShift work$75k - $95k
...changing treatments to patients and families who need them most. Quality Control Associate II/III, Analytical will perform analytical... .... This role is central to ensuring product quality and regulatory compliance for Capricor’s cell‑based and exosome‑based therapeutic...RegulatoryContract work$70.3k - $82k
...goals and targets.About This JobAs the AVP, Compliance Officer, you will play a pivotal role in... ...executing compliance risk assessments, quality assurance reviews, and compliance... ...will support business units in navigating regulatory changes, marketing compliance, and company...RegulatoryWork at officeLocal area$100k - $120k
...About the role: The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within... ...quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU...RegulatoryLocal areaFlexible hours$75k - $83k
...Sr. Quality Assurance Specialist Location: San Diego, CA | Employment Type: Full-Time Join a team... ...who is passionate about quality, compliance, and continuous improvement. In this... ...commercial products meet the highest regulatory and quality standards while contributing...RegulatoryFull timeContract workCasual workWork at officeWorldwideAfternoon shift- ...families who need them most. The Corporate Compliance Officer is responsible for leading,... ...reporting requirements, document retention, quality compliance, anti-corruption, data... ...with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities...Regulatory
- Summary The Corporate Compliance Officer is responsible for leading, developing, and overseeing... ...requirements, document retention, quality compliance, anti-corruption, data privacy... ...with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities...Regulatory
$120k - $150k
...key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA... ...Functions: The Senior QS Specialist II will be expected to... ...ensure compliance with regulatory requirements and... ...in the medical device, IVD or other regulated industry...RegulatoryWork at office- ...knowledge and experience 10+ years Quality Assurance experience in a... ...data and potential quality/compliance concerns escalating to... ...defendable interpretations of regulatory guidance for the customer and... ...) Quality Assurance Senior Specialist supports clinical trial projects...Regulatory
$85k - $89k
Quality Assurance Specialist II Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) Catalent... ...trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and...RegulatoryContract workWork experience placementWorldwideMonday to Friday$86k - $115k
...This role is responsible for supporting and executing Quality Assurance and Quality Compliance activities to ensure cGxP compliance across the organization... ...continuous improvement initiatives. Participate in regulatory agency and third-party inspections by supporting...RegulatoryWork at officeLocal areaFlexible hours- ...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 placementWork at office
$28.85 - $34.62 per hour
...all work from their homes. Position Overview The Business Systems & Compliance Analyst supports the organization’s Quality Management System (QMS), operational compliance initiatives, and regulatory processes in accordance with ISO 13485, ISO 27001, FDA requirements,...RegulatoryHourly payFull timeRemote workWork from home- ...Regulatory Affairs Specialist III Advance your career in beautiful San Diego! A Top-Tier Global Life Sciences Leader is seeking a Regulatory Affairs... ...strategies for high-scrutiny In-Vitro Diagnostic (IVD) blood-screening product lines, collaborating closely with...Regulatory
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