Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Specialist: IVD Submissions Lead in San Diego, CA vacancy
  • $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

    Grifols, S.A

    San Diego, CA
    7 hours ago
  •  ...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

    San Diego, CA
    2 days ago
  • 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

    Jobtailor

    San Diego, CA
    3 days ago
  • 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

    Barrington James

    San Diego, CA
    1 day ago
  • $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... 
    Suggested
    Full time
    Contract work
    Work at office
    Local area

    Grifols, S.A

    San Diego, CA
    7 hours ago
  • 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... 
    Senior
    Contract work

    Viltis

    San Diego, CA
    17 hours ago
  • 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

    CorDx

    San Diego, CA
    4 days ago
  • 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

    Viltis

    San Diego, CA
    17 hours ago
  •  ...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 Therapeutics
    Senior
    Remote job

    Travere Therapeutics

    San Diego, CA
    4 days ago
  •  ...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

    Viking Therapeutics, Inc.

    San Diego, CA
    7 hours ago
  • $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... 
    Senior
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    RayzeBio

    San Diego, CA
    4 days ago
  • 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

    RXinsider LTD.

    San Diego, CA
    4 days ago
  • 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... 
    Senior
    Immediate start

    Smps-Oc

    San Diego, CA
    1 day ago
  • $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... 
    Senior
    Full time
    Work at office

    Insulet Corporation

    San Diego, CA
    1 day ago
  • $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... 
    Senior
    Temporary work
    Local area

    Slalom

    San Diego, CA
    1 day ago
  • 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... 

    n-Lorem

    San Diego, CA
    2 days ago
  • 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... 
    Senior
    Work at office

    Client Solution Architects

    San Diego, CA
    1 day ago
  • 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

    Northrop Grumman

    San Diego, CA
    2 days ago
  • $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... 
    Senior
    Full time
    Relocation package
    Shift work

    Northrop Grumman

    San Diego, CA
    1 day ago
  •  ...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

    PCI TRGR Penn Pharmaceutical Services Ltd

    San Diego, CA
    7 hours ago
  • $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 /... 
    Senior
    Full time
    Remote work
    Flexible hours
    Shift work

    GoFundMe

    San Diego, CA
    7 hours ago
  • $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... 
    Senior
    Full time
    Temporary work
    Work at office
    Flexible hours

    Greenberg Traurig LLP

    San Diego, CA
    13 hours ago
  •  ...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,... 
    Senior
    Full time
    Contract work
    Summer work
    Work at office
    Remote work
    Shift work

    QuidelOrtho Corporation

    San Diego, CA
    13 hours ago
  • 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... 
    Senior
    Remote work

    Northrop Grumman

    San Diego, CA
    7 hours ago
  • $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... 
    Senior
    Full time
    Temporary work
    Relocation package

    Zoox

    San Diego, CA
    3 days ago
  • 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

    Sony Electronics

    San Diego, CA
    3 days ago
  • 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

    Tag Management Inc

    San Diego, CA
    2 days ago
  • 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

    Intuit

    San Diego, CA
    1 day ago
  •  ...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

    Galapagos Federal Systems LLC.

    San Diego, CA
    2 days ago
  • $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

    Proven Recruiting

    San Diego, CA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist: IVD Submissions Lead. Be the first to apply!