Senior Regulatory Affairs Specialist
FUJIFILM Holdings America Corporation
FUJIFILM Biosciences in Santa Ana, CA is seeking a Senior Regulatory Affairs Specialist to manage licensing, filings, and regulatory compliance across US and international lines. You will collaborate with QA, R&D, and manufacturing to prepare DMFs, respond to agency inquiries, and support audits; requires 3–5 years in medical device/pharma and strong knowledge of GMP/CFR/ISO standards. #J-18808-Ljbffr
- ...A clinical stage startup in Irvine, CA is seeking a Principal Regulatory Affairs Specialist to lead the execution of key U.S. FDA submissions for Class III cardiovascular medical devices. The role involves developing regulatory strategies, partnering with cross-functional...Senior
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...SeniorWork at officeLocal area3 days per week
$95.8k - $159.6k
...Work Flexibility: Hybrid or Onsite Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy...SeniorFor contractorsLocal area$170k - $200k
...Would you like to be part of our story? Don\'t hesitate, come and join us! Description About this opportunity – Senior Principal Regulatory Affairs Specialist The Sr. Principal Regulatory Affairs Specialist is a seasoned expert, responsible for completing and...Senior- Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess...Senior
- ...future - including your own.We’re actively seeking a talented Senior Compliance Analyst to join our Distribution & Marketing Compliance... ...and approving marketing and sales material, providing regulatory consultation, and providing solutions to help meet the business...SeniorFull timeWork at officeFlexible hours
$99.7k - $152.08k
The Sr. Export Compliance Specialist supports the company’s export compliance program to ensure compliance with U.S. export control regulations and protect sensitive technology and information. This role partners cross-functionally to provide practical compliance guidance...SeniorPermanent employmentFull timeFor contractorsCasual workWork at office$129k - $171k
...to the United States and its allies. Operating in a fast-growing, high-impact environment, we take creative ownership of complex regulatory matters to build and manage efficient, top-tier compliance processes. We are deeply passionate about the law and policy of defense...SeniorFull timeFor contractorsWork experience placementImmediate start$85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products...SeniorWork experience placementLocal areaWorldwideFlexible hours- ...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in... ...preferred Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international...Senior
- ...Kura Sushi USA in Irvine, CA is seeking a GRC Senior Regulatory Compliance Analyst to join our hybrid team. You will assist the Integrated GRC Senior Manager to ensure Kura meets legal, regulatory and internal standards across operations, contracts and vendor engagements...Senior
- UCI Health seeks an experienced credentialing professional to perform a full range of responsibilities within credentialing practices. The role supports Medical Staff bylaws, state and federal laws, and NCQA standards, coordinating meetings and reports while ensuring licensure...Senior
- A leading technology firm in Anaheim, California seeks a Trade Compliance Senior Specialist to oversee export/import compliance and ensure adherence to federal regulations. Ideal candidates should have a Bachelor’s Degree and at least 6 years of relevant experience, including...SeniorRelocation package
$95.8k - $159.6k
...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product...SeniorFull timeLocal area- ...in-office presence required based on division responsibilities and business needs. This is not a remote position. The GRC Senior Regulatory Compliance Analyst, who has proficient knowledge in regulatory compliance rules and regulations will be responsible for assisting...SeniorContract workWork at office1 day per week
- ...environments including Google Cloud Platform (GCP), Microsoft Azure, and Amazon Web Services (AWS). This role partners with the CISO and senior leadership to modernize security capabilities, enforce architectural standards, and enable secure digital transformation. Your role...SeniorFull time
$84k - $118.11k
...Consumer Regulatory Compliance Senior Consultant Are you interested in joining one of the fastest growing consulting and accounting firms in the country? Would you like the ability to join a highly dynamic team focused on providing exceptional client service in the...SeniorWork experience placement$42.7 - $56.47 per hour
Job Title: Senior Trade Compliance Classification Analyst Pay rate: $42.7 - $56.47/hr. Location: Irvine, CA Zip Code: 92606 Duration... ...against sanctions lists, and filing required information with regulatory authorities to ensure shipments move without delay. Key...SeniorContract workTemporary workImmediate startWorldwide- ...Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate routine regulatory activities across domestic and international markets, supporting product registrations, submissions, and post-market requirements. You will manage regulatory information...
$80k - $95k
...become available. Subscribe to our RSS feeds to receive instant updates as new positions become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities that support the company’s worldwide medical...Work at officeWorldwideWeekend workAfternoon shift$84.72k - $120k
...Sr. Regulatory Affairs Specialist We are seeking an experienced Sr. Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. In this role, you'll lead FDA 510(k)/PMA filings, maintain international registrations, support...Senior- ...Sr. Export Compliance Specialist The Sr. Export Compliance Specialist supports the company's export compliance program to ensure compliance with U.S. export control regulations and protect sensitive technology and information. This role partners cross-functionally...SeniorFor contractorsCasual workWork at office
$92k - $130k
...Join Our Regulatory Affairs Team Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in...SeniorWork experience placement$81.8k - $130.9k
Senior Trade Compliance Specialist page is loaded## Senior Trade Compliance Specialistlocations: Irvine, CA, United States of Americatime type: Full... ...by Supervisor* Administrative support for required regulatory reporting requirements in a timely manner.**Export Control...SeniorTemporary workImmediate startWorldwideFlexible hours$129k - $171k
...Export Compliance, Senior Analyst Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative...SeniorFull timeFor contractorsWork experience placement- Anduril Industries in Costa Mesa, CA seeks a Senior NNPI Control Officer to build, lead, and enforce the NNPI Protection Program across its Maritime business line. You will ensure compliance with NAVSEA NN-801, N9210.3, and DoD CUI guidelines while coordinating with engineering...Senior
$32.5 - $36 per hour
Job Description Overview\n Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States. This unique opportunity combines tax expertise...SeniorLocal area- Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate global product registrations and regulatory submissions across markets. The role ensures timely documentation, maintains records, and collaborates with cross‑functional teams to meet regulatory...
- ...Principal Regulatory Affairs Specialist Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed...Work at officeRemote work
- Anduril Industries in Costa Mesa, CA is seeking an experienced Information Systems Security Manager to lead security controls, risk assessments, and continuous monitoring across classified deployments. You’ll work with program teams to tailor standards, implement encryption...Senior
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