Senior Regulatory Affairs Specialist: IVD Submissions Lead
Barrington James
Barrington James in San Diego seeks a Regulatory Affairs Specialist/Senior Specialist to lead complex global submissions (FDA, EU Notified Bodies) and guide product lifecycle compliance in a fast‑paced diagnostics environment. Strong communication and project management skills are essential to translate science into regulatory strategy. You will collaborate with R&D, Quality, Clinical, and Engineering to assemble technical documentation, manage health authorities, and mentor junior staff while #J-18808-Ljbffr Barrington James
$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...Senior- ...to guide SAS programming across clinical data analyses and submissions. You will lead teams and coordinate biometrics activities, ensuring CDISC... ...programmers, drive vendor collaborations, and oversee regulatory deliverables such as DSURs, IB updates, and e-submission components...Senior
- Jobtailor in San Diego seeks a Senior Medical Writer with oncology focus to provide strategic... ...writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions. Requirements include a PhD preferred,...Senior
- Regulatory Affairs Specialist/Senior Specialist We're currently supporting A global healthcare... ...post-market regulatory submissions with the US FDA, Notified... .... Key Responsibilities: Lead preparation, submission, and... ...authorities) for IVD products. Develop regulatory...Senior
$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular Full-Time Area... ...market and post‑market regulatory submissions with the US FDA, Notified Bodies... ...able to identify mitigation plans, lead mitigation projects, and make...SuggestedFull timeContract workWork at officeLocal area- Senior Regulatory Affairs Specialist - Medical Devices Clinical San Diego , California Contract Aug 10, 202... ...Regulatory Affairs Specialist to support a leading medical device organization in San... ...and U.S. medical device submissions . This individual will serve as a regulatory...SeniorContract work
- CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle. You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant...Senior
- Viltis is seeking a Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA. The ideal candidate brings 7+ years... ...in regulatory change assessments and U.S. submissions. You will partner with Quality, Engineering, Manufacturing...Senior
- ...Biologics Drug Substance Manufacturing to lead technical oversight of biologics... ...production with collaboration across Quality and Regulatory. Ideal candidate has deep microbial... ...experience, and prior work supporting BLA submissions. #J-18808-Ljbffr Travere TherapeuticsSeniorRemote job
- ...seeking a Sr. Manager, Medical Writing to lead clinical and regulatory documentation across development... ..., CSRs, IBs, and regulatory submissions, ensuring accuracy, consistency, and... ...with Clinical Development, Regulatory Affairs, and Biometrics to deliver high-quality...Senior
$258.68k - $313.46k
...us.Sr Director, Global Regulatory Strategy,... ...as Global Regulatory Lead and US Regional Regulatory... ...impact BMS, regulatory affairs or projects and provides... ...regulatory product managers (submissions) and regulatory... ...with Ripley.R1603594 : Senior Director, Global Regulatory...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Dexcom Corporation is seeking a Regulatory Affairs professional to support regulatory activities for Dexcom software products and develop global regulatory strategies for submissions in the US, EU and Canada. You will collaborate with regional teams, review software labeling...Remote job
- SOCOTEC US in Irvine, CA is seeking a Senior Proposal Coordinator to join our marketing team in San Diego. You will coordinate preparation... ...in response to RFPs and Qs, ensuring timely and accurate submissions. This role collaborates across departments to gather...SeniorImmediate start
$91.7k - $137.53k
Job SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering...SeniorFull timeWork at office$158k - $217k
Snowflake Partner Solution Lead - West RegionAs a Snowflake Partner Solution Lead, you will take the helm of one of Slalom’s most critical... ...and 7-time Snowflake Partner of the Year, you will act as a senior technical and commercial authority at the intersection of...SeniorTemporary workLocal area- n-Lorem Foundation seeks a Regulatory Operations Coordinator/Manager to lead the operational aspects of US regulatory activities within a fast-paced biotech... ...with preclinical and clinical teams to develop submission-ready documents and maintain regulatory quality across...
- San Diego, CAJob TypeFull-timeDescriptionCSA is seeking a Senior Configuration Management (CM) Lead in support of the PMW/A 520 Program Office onsite in San Diego. CA.This individual will be responsible for directing and managing Configuration Management activities, establishing...SeniorWork at office
- Northrop Grumman Aeronautics Systems in Rancho Bernardo, CA, seeks a Senior Principal Systems Engineer to lead a diverse engineering team in delivering imaginative solutions across the Systems Engineering V-Model. The role covers requirements development, use case development...Senior
$142.2k - $213.4k
...history.Northrop Grumman Aeronautics Systems has an opening for a Senior Principal Systems Engineer to join our team of qualified,... ...Engineer for the NATO Business Area. You will be responsible for leading a diverse engineering team to provide imaginative, technical solutions...SeniorFull timeRelocation packageShift work- ...their Microbiology lab in San Diego, CA. This role coordinates laboratory activities, manages a team, and ensures compliance with regulatory requirements. The ideal candidate will have a Bachelor’s in Life Sciences and at least five years of experience in Microbiology,...Senior
$90k - $135k
Join to apply for the Senior Compliance (GSEDD)... ...staying current on regulatory changes, industry guidance... ...Manager, Regulatory Affairs Senior Compliance Specialist (San Diego Onsite)... ...Payments Compliance Lead San Diego, CA $142,0... ...Affairs Manager - IVD and 510K Manager /...SeniorFull timeRemote workFlexible hoursShift work$260k - $365k
...an exciting full-time employment opportunity for a senior level Associate in the Financial Regulatory & Compliance Practice. This position can be filled... ...please submit your resume and official transcript(s).*Submissions from search firms will only be accepted through our...SeniorFull timeTemporary workWork at officeFlexible hours- ...Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in... ...for a healthier future for all. Join our mission as our next Senior Global Procurement Lead. This position will provide leadership,...SeniorFull timeContract workSummer workWork at officeRemote workShift work
- Northrop Grumman Aeronautics Systems seeks a Senior Principal Project Manager to lead IPT activities on-site in Palmdale, CA, San Diego, CA, or Oklahoma City, OK. The role requires top-secret clearance and experience managing complex engineering programs with cost and...SeniorRemote work
$206k - $282k
.../ San Diego, CASoftware - Software Platforms and Product /Full-time /HybridAs a Firmware Connectivity Systems Integration and Test Lead on the Embedded Software team, you will own the performance, optimization, and debugging of our TCU (Telematics Control Unit). Managing...SeniorFull timeTemporary workRelocation package- Sony Electronics in San Diego seeks a Senior Communications Specialist to drive consumer-facing PR for imaging products, including cameras and lenses. You will own media relations, social media, and creator programs, collaborating across functions to tell compelling technology...Senior
- Plumb seeks a Senior Client Relationship Associate to independently manage larger, more complex client portfolios and serve as the primary... ..., and ownership of client outcomes, with a path toward Lead CRA through consistent retention and growth of a high-value book...Senior
- Intuit is seeking an Investigator to join their Ethics & Investigations team. This role involves investigating concerns related to ethical violations and conducting impartial investigations. Candidates should have strong critical thinking and interpersonal skills, alongside...Senior
- ...support PMW 120 in NAVWAR C4I. The role focuses on PPBE budgeting, scheduling, and resource alignment to mission priorities, delivering senior acquisition support across IT, engineering, and mission areas. Ideal candidates bring 10+ years of DoD experience, TS/SCI clearance...Senior
$115k - $128k
A growing healthcare company in San Diego is seeking a Senior Financial Analyst to enhance financial modeling and revenue processes. This role involves collaborating across departments to drive efficiency and communicate insights effectively. Ideal candidates have extensive...Senior
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