Senior Regulatory QA Specialist — FDA & QMS Writing
Dexcom Inc.
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 judgment. The position offers opportunities for professional growth within an innovative organization committed to impacting lives through CGM technology, alongside a comprehensive benefits program. #J-18808-Ljbffr Dexcom Inc.
$85.12k - $95.76k
...Sr. Compliance Specialist The Sr. Compliance... ...adherence to applicable regulatory requirements and... ...requirements (e.g., FDA, DEA, and... ...Management System (QMS) activities including... ...years of relevant QA experience in a GMP... ...to speak, read, and write fluently and accurately...SeniorFull timeFlexible hoursWeekend work$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... ...in Regulatory Affairs. Strong analytical and technical writing skills are essential. The role offers a salary range of approximately...Senior$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...SeniorTemporary work$120k - $135k
...tandemdiabetes.com A Day In The Life The Sr. Regulatory Affairs Specialist is responsible for developing... ...Demonstrated experience in leading, designing, writing, and submission of regulatory filings... ...with regulatory agencies including FDA, Health Canada and EU regulatory...SeniorWork at officeLocal areaRemote workWorldwideWork visaFlexible hours2 days per week3 days per week$92k - $115k
...ability to coordinate across site teams, engineering, legal, and regulatory stakeholders. Strong judgment, follow-through, and cross-... ...stakeholders. Excellent communication, facilitation, and report-writing skills. Ability to build dashboards and reporting tools that...SeniorH1bWork at officeLocal areaRelocationVisa sponsorshipFlexible hours$94.78k - $128.23k
...QA Sr Specialist Job Locations US-CA-San Diego Requisition ID 2026-35775 Position Type Full Time Position... ...Improvement. Quality Inspection. Quality Management System (QMS). Physical Requirements Must be able to remain in a stationary...SeniorFull timeContract workTemporary workWork at officeShift work$94.78k - $128.23k
...Knowledge, skills & abilities: Batch Testing. Inspection. Nondestructive Testing. Product QA. Quality Assurance Process. Quality Improvement. Quality Inspection. Quality Management System (QMS). Physical Requirements Must be able to remain in a stationary position at...SeniorContract workTemporary workWork at officeShift work$75k - $83k
...leading peptide manufacturing company in San Diego is looking for a Senior Quality Assurance Specialist. In this role, you will ensure compliance with regulatory quality standards, participate in critical QA activities, and collaborate with various teams to support the...Senior$75k - $83k
PolyPeptide in San Diego, CA is seeking a Senior Quality Assurance Specialist to ensure that clinical and commercial products meet regulatory and quality standards. You will oversee... ...compliance. The ideal candidate has 5-7 years of QA experience in the pharmaceutical sector...SeniorFull time$95k - $105k
ACON Laboratories in San Diego is seeking a Regulatory Affairs Specialist III to oversee the preparation of regulatory submissions for medical devices... ...have significant experience in IVD and be familiar with FDA and CE regulations. The role involves drafting technical files...Senior$75k - $87k
...Description Title: Sr. HR Compliance Specialist Category: Full-Time Status: Exempt... ...training of managers and departments on regulatory and compliance issues Assist with... ...employment laws Excellent communication and writing skills with internal and external...SeniorFull timeFor contractorsLocal areaImmediate startFlexible hours- ...biotech firm in San Diego is seeking an experienced QA Consultant (GxP) to enhance Quality Systems.... ...overseeing Quality Management Systems (QMS), managing GxP quality processes, and ensuring compliance with regulatory standards. Ideal candidates will have over 8 years...Senior
$86.4k - $135.1k
...life sciences company in San Diego is seeking a Quality Assurance Specialist 3 to ensure compliance and operational excellence. In this role... ...quality initiatives and maintain Quality Management Systems (QMS) according to state and federal regulations. Candidates should...Senior- ...neuroendocrine and neuropsychiatric disorders. Our portfolio includes FDA‑approved treatments for tardive dyskinesia, chorea associated... ...monitoring and analytics. This role will focus on translating regulatory requirements and risk insights into actionable dashboards, key...Senior
$85k - $100k
...fuels as well as renewable fuels. The Senior Associate Chemical Engineer will be responsible... ...engagements that generally relate to regulatory compliance. Day-to-day work will... ...strong decision-making skills * Excellent writing and presentation skills * Adjusts style...SeniorFull timeWork at officeImmediate startFlexible hours$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular Full... ...and post‑market applications to FDA, EU Notified Bodies, and other international... ...the organization. Strong technical writing skills with ability to translate scientific...Full timeContract workWork at officeLocal area$95k - $105k
...of our growing, dynamic company. The Regulatory Affairs Specialist III will coordinate the accumulation of... .... Prepare regulatory submissions (FDA 510(k)s, technical files for CE Marking... ...and oral communication, and technical writing and editing skills; Ability to write...Work at officeRelocation$24 - $34 per hour
Werfen is searching for a Temporary Document Control Specialist III in San Diego, California, who will guide, execute, and improve Document... ..., ensuring compliance with organizational standards and regulatory requirements. Candidates must have a Bachelor's degree and a minimum...SeniorHourly payTemporary work$193k - $220k
...and applies advanced systems methods, theories and research techniques. Directs, coordinates and contributes to compilation and writing of proposal documents. Prepares design proposals to reflect cost, time and alternative solutions. Provides functional or resource...SeniorFor subcontractor$102.25k - $132.92k
...supply chain actions performed Product Specialists in order to provide effective/efficient... ...minimum qualifications, and any other regulatory requirements by the cut-off/closing date... ...illegal . Additional guidance on writing a federal resume can be found at:...Permanent employmentFull timePart timeRemote workRelocationTrial period$70.51k - $91.66k
...May work with higher-level Equipment Specialists to recommend revisions to repair manuals... ...minimum qualifications, and any other regulatory requirements by the cut-off/closing date... ...illegal . Additional guidance on writing a federal resume can be found at:...Permanent employmentFull timePart timeLocal areaRemote workRelocation- ...Senior Data Integrity Consultant A leading biotechnology... ...compliance with global regulatory standards to support... ...compliance with FDA (21 CFR Part 11/210/211... ...Quality Management Systems (QMS), including Change... .... ~ Strong technical writing, communication, and analytical...SeniorLocal areaShift work
$142.2k - $213.4k
...Northrop Grumman Aeronautics Systems has an opening for a Senior Principal Systems Engineer - IFC Management to join our team of... ...proposal development. Demonstrated communication and technical writing skills. Proven ability to brief technical presentations to...SeniorFull timeRemote workRelocation packageShift work- ...Associate Director Regulatory Affairs - Hybrid - San Diego We are partnering with a clinical... ...portfolio, supporting interactions with FDA and other global health authorities, and... ...Operations, CMC, Nonclinical, Biometrics, Medical Writing, and Quality teams to align regulatory...Odd job
$70k - $82k
...readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). ~ Perform gap... .... ~ Collaborate with QA/QC, Manufacturing, Regulatory, Supply... ...Control). ~ Strong technical writing skills and attention to detail; able...$89.22k - $122.67k
...their career. As a Quality Specialist, you will be... ...audits and hosting/support FDA inspections. Serve as... ...Experience in interpreting regulatory policies and guidance documents... ..., investigation writing, and management of... ...travel 10% - 25%. Relevant QA experience for 3-5...Temporary workLocal area$85k - $89k
Position Summary Quality Assurance Specialist II - supports clinical trial projects through quality assurance processes throughout the... ...Validation Systems Participate in investigations and deviation writing Support client communications Review and approve change controls...Monday to Friday$85k - $89k
Quality Assurance Specialist II - San Diego By Catalent, Inc., a leading global contract development... ...projects by ensuring compliance with regulatory requirements, good manufacturing... ...Participate in investigations and deviation writing. Support client communications. Review...Contract work$90k - $110k
...Operations team and support the design of a robust, data-informed QA framework for a defined pod(s) and/or line(s) of business. This... ...fluency: Proficient at independently exploring datasets, writing queries, and building dashboards or analyses with analytics/BI tooling...Work at officeRemote workFlexible hours$80k - $120k
An innovative fundraising platform is hiring a Senior Regulatory Affairs Governance Analyst to lead the development of compliance frameworks and governance structures. The role involves conducting regulatory gap analyses, advising teams on compliance, and shaping policies...SeniorRemote work
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