Senior Regulatory Affairs Specialist, FDA Submissions
Calyxo
Calyxo, Inc. in Pleasanton, CA, seeks a Senior Regulatory Affairs Specialist to independently manage US and international regulatory filings for category-defining medical devices. Join a cross-functional team spanning R&D, Operations, Quality, Clinical, and Legal to ensure regulatory alignment from concept through commercialization while balancing speed with compliance. The ideal candidate has FDA experience, strong technical writing skills, and practical knowledge of US and international #J-18808-Ljbffr Calyxo
$90k - $180k
...Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... ...We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site... ...applications for FDA and/or international regulatory... ..., and submits regulatory submissions, including European...SeniorFor contractorsWorldwide- ..., Inc. is looking for a Staff Regulatory Affairs Specialist in Pleasanton, California. This senior role requires 12+ years in regulatory... ..., focusing on leading complex submissions and ensuring regulatory... ...ideal candidate has extensive FDA experience and a proactive mindset...Senior
- ...Summary We are seeking an experienced Senior Regulatory Affairs Specialist to support our growing Regulatory... ...moderately complex U.S. and international submissions, and provide strong cross-functional... .... The ideal candidate brings solid FDA experience, working knowledge of...SeniorWork at officeWorldwideShift work
$90k - $180k
...Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... .... The Opportunity This Senior Regulatory Affairs Specialist will work out of our... ...of product registration submission, progress reports, supplements... .... • Interacts with FDA and other regulatory agency...SeniorFor contractorsWork experience placementWork at office- ...staffingfuture.comOverview: We are seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team. The ideal candidate will manage and... ...Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics....Suggested
- ...#CloroxIsThePlaceYour role at Clorox:The Regulatory Affairs Specialist II provides regulatory leadership to... ...compliance and safety of Clorox’s FDA-regulated Foods portfolio, including... ..., Kosher, Halal, Organic).Coordinate submission dossiers, data verification, and renewal...Full timeSummer workWork at officeRemote workFlexible hours3 days per week
- ...innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities. This is... ...Prepare and manage submissions including FDA 510(k), EU MDR Technical Documentation, CE...SeniorLocal area
- ...Senior Compliance Analyst Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented team. Role Overview: The Sr. Compliance Analyst within...SeniorWork at office
$73.9k - $116k
...treatment. The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton, CA... ...skills in product registration submission, change order management, progress reports... ...with U.S. Food and Drug Administration (FDA) and international regulations, other...Work experience placement- ...Laboratories in Pleasanton, CA is seeking a Regulatory Affairs Specialist to support regulatory activities and... ...supervision to ensure timely regulatory submissions. You will review engineering changes, maintain compliance with FDA and international regulations, and help...
$139.9k - $280.6k
...for national security and technology innovation, with teams of specialists focused on cutting-edge work in a broad array of areas. Some... .... Posting Duration This posting will be open for application submissions for a minimum of three (3) calendar days, including the '...SeniorTemporary workPart timeRemote workWork from homeWorldwideRelocation packageFlexible hours- ...People Business Partner to join our team in Pleasanton, CA. You will drive HR strategy, lead executive coaching, and partner with senior leaders to align workforce plans with business objectives. The role requires 12+ years of HR leadership, exceptional communication...SeniorRemote workFlexible hours
$139.9k - $280.6k
...and technology innovation, with teams of specialists focused on cutting-edge work in a broad... ...related high-pressure components. This senior technical role focuses on applying... ...This posting will be open for application submissions for a minimum of three (3) calendar days...SeniorPart timeRemote workWork from homeWorldwideRelocation packageFlexible hours- Sandia National Laboratories in Livermore, CA seeks an experienced Systems Engineer (R&D S&E) to develop high-impact national security capabilities. You will work in a team-focused environment, collaborating across IT, software, and engineering disciplines to deliver rigorous...Senior
$130.56k - $179.52k
DescriptionPOSITION:Senior Software Engineer-- or -- Senior Staff Software Engineer -- or --Principal Software EngineerPosition Level: The best fit candidate selected for this position will be offered a job title/level (Senior Software Engineer vs. Senior Staff Software...SeniorRemote work- FormFactor, Inc. seeks a Sr Principal Technical Support Engineer in Livermore, CA, with strong expertise in probe card technology and wafer testing. You will serve as a key interface among customers, product engineering, and field service to ensure rapid issue resolution...SeniorRemote job
$139.9k - $280.6k
The Accreditation Council for Graduate Medical Education seeks mission-focused candidates for critical roles in the Livermore, CA facility. Successful applicants will develop tactics, drive engineering projects, and collaborate across disciplines to ensure mission success...SeniorFlexible hours- Abbott in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support worldwide submissions and regulatory strategies for medical devices. The role collaborates with product teams and manufacturing to prepare filings and maintain licenses, registrations,...SeniorWorldwide
- ...Pleasanton, CA, is seeking an experienced Senior Regulatory Affairs Specialist to support our growing regulatory... ...will manage U.S. and international submissions and partner with R&D, Quality,... ...timely market entry. You bring solid FDA experience, leading submissions such...Senior
- ...Inc. in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities from concept... ...You will own U.S. and international submissions and partner with R&D, Operations,... ...plans. The ideal candidate has FDA experience, strong technical writing...Senior
$228k - $342k
...and we hope to be a match for you too.About the TeamAgent Factory is where Workday’s next chapter gets built. We’re forming small, senior, cross-functional AI teams that bring together product leaders, machine learning engineers, and full-stack builders to create intelligent...SeniorFull timeWork at officeRemote workHome officeFlexible hours- ...subject matter expert, driving effective tax strategies, ensuring regulatory compliance, and managing relationships with external tax... ...schedules and reviewing complex information and/or documentation for submission to internal and external auditors, and the Tax department....SeniorFixed term contractWork experience placementWork at officeLocal area
$78k - $105k
...Senior Finance Associate The Senior Finance Associate will provide analytical support to their designated region. This person will... ...to apply at ABM does not accept unsolicited resumes or submissions outside of this portal. Applicants should submit their application...SeniorLocal area$90k - $180k
...people in more than 160 countries.Job Title Senior Electrical Engineer, Medical Devices... ...for concept feasibility and formal regulatory submission Contribute to the continuous improvement... ...and regulatory requirements of Abbott, FDA and ISO regulations Comply with U.S. Food...SeniorFor contractorsRemote workWorldwide$207k - $310.6k
...all audience levels and deliver expert advice through engaging presentations. ~ Builds positive relationships and can influence senior leaders, knowing when to challenge and when to agree. ~ Track record of using data and insights from internal and external sources...SeniorWork at officeRemote workHome officeFlexible hours$48 - $67 per hour
...designers Check completed work for quality, clarity, and use of ACCO BIM standards Prepare project-deliverable packages for submission Communicate design and constructability issues/challenges with project team Effectively and professionally communicate and...SeniorHourly payTemporary workWork experience placementMonday to Friday$70 per hour
...billion dollar manufacturing organization for a contract role as a Staff Regulatory Affairs Specialist. This role will be part of the regulatory team and will focus on preparing FDA regulatory submissions to support product clearances and approvals. An ideal candidate will...Hourly payContract workTemporary workWork experience placementLocal area$104.13k - $175.6k
...line(s) of business, while serving as a senior-level underwriting and distribution partner... ...underwriting targetsRemain current on regulatory, rating, and coverage changes (e.g.,... ...across Commercial Lines Ability to evaluate submissions, financials, and loss data to support...SeniorFull timeWork at officeLocal area- Join our team as a Senior Warehouse Coordinator and play a key role in optimizing warehouse operations, managing inbound and outbound logistics, and supporting staff development. If you have strong organizational skills, experience in warehouse proceSenior
$182.9k - $274.3k
...hard and have fun together.About the RoleWe are looking for a Senior Manager, International Tax to serve as a key in‑house subject... ...filings across multiple jurisdictions, driving timely, accurate submissions and clear communication and documentation of risks and issues....SeniorFull timeWork at officeLocal areaRemote workHome officeOverseasFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist, FDA Submissions. Be the first to apply!
- compliance coordinator Pleasanton, CA
- regulatory specialist Pleasanton, CA
- compliance associate Pleasanton, CA
- risk and compliance analyst Pleasanton, CA
- regulatory officer Pleasanton, CA
- compliance specialist Pleasanton, CA
- compliance officer Pleasanton, CA
- regulatory affairs specialist Pleasanton, CA
- coding compliance specialist Pleasanton, CA
- healthcare compliance officer Pleasanton, CA

