Senior Regulatory Affairs Specialist
MILLENNIUMSOFT
A reputable medical devices company is seeking a Senior Regulatory Affairs Coordinator for an onsite position in Irvine, CA. The role involves supporting US and EU regulatory submissions, developing regulatory strategies, and providing guidance on registration. Candidates should possess a Bachelor's degree in a scientific discipline and have 5-7 years of relevant experience. Strong skills in Microsoft Office, communication, and problem-solving are essential. Contract employment on W2 is required, with a commitment of 40 hours per week. #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
- ...Job Title: Senior Specialist, Regulatory Affairs Role Level: Individual Contributor Supervisor/Manager Title: Senior Manager, Regulatory Affairs Job Location & Environment: Irvine, CA – Corporate Office Environment Job Description Summary: Responsible for global regulatory...SeniorWork at office
- ...cardiovascular and interventional space. As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities across the product lifecycle. This is...Senior
- ...ByteLight is seeking a Senior Analyst, Trade Operations Americas to lead regulatory oversight of imports/exports across the U.S., Mexico, Canada and LATAM. The role reports to the Senior Manager, Global Trade Compliance Operations and requires close collaboration with...Senior
- ...University of California, Irvine is seeking a senior Research Compliance professional to oversee institutional research integrity, sponsored research accountability, and regulatory compliance activities. The role applies expert knowledge of federal, state, and university...SeniorRemote work
- ...Western Alliance Bank is seeking a Compliance Consultant in Irvine, CA. This role involves providing expertise in regulatory compliance, overseeing risk management, and collaborating across various business lines. Ideal candidates will have over 6 years of related experience...Senior
- ...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 the acceptability of documentation...Senior
$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$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- ...loanDepot in Irvine, California is seeking a Fair Lending Compliance Specialist responsible for managing compliance initiatives related to fair lending. The role entails preparing reports, conducting performance analyses, and ensuring compliance with various regulations...Senior
- ...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
- ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge... ...team fit are paramount. The Principal Regulatory Affairs Specialist is a senior technical expert and strategic problem solver within...Full timeContract workRemote work3 days per week
- ...The Senior Trade Compliance Specialist is responsible for ECCN and HTS classification of technology products and export license determination while... ...process flows, and FAQs Conduct compliance audits and prepare regulatory reporting Prepare metrics, KPIs, and reporting on...Senior
- ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare Quality Assurance/Regulatory reports and present status in review meetings...Immediate start
- ...Prismatik Dentalcraft is a division of Glidewell Dental. We are seeking an experienced 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...
- ...ConsultNet Technology Services and Solutions is hiring a Jr. Regulatory Affairs Specialist in Irvine, CA to support product development teams with regulatory inputs, strategies, and design controls. You will prepare QA/regulatory reports and present status in review meetings...
- ...Jenavalve Technology Inc in Irvine, CA, seeks a Senior Specialist in Regulatory Affairs to lead global regulatory activities. The role involves preparing regulatory submissions, overseeing reporting, and ensuring compliance with medical device regulations. The ideal candidate...
- ...Jenavalve Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong focus on managing regulatory communication and submissions. The role requires substantial experience in medical device regulations, ensuring compliance with quality standards...
- ...Job Summary The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn’s pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits...
$174.8k - $221.82k
...while still pushing artistic boundaries to fully capture the unique tone and unforgettable atmosphere of the Arkheron’s world. As a Senior/Principal Character Concept Artist at Bonfire, you’ll help shape the look and feel of Arkheron by creating characters that are both...SeniorFull timeImmediate start- ...infrastructure, and commercial and residential development. We work hard. We play hard. We have fun. JOIN CANNON as a CIVIL SENIOR PRINCIPAL ENGINEER LAND DEVELOPMENT in IRVINE. Irvine offers warm weather, beautiful scenery, and is a top bicycling city with miles...Senior
- Edwards Lifesciences is seeking a Regulatory Affairs professional in California to guide submissions for domestic and international devices. You will collaborate with manufacturing and development teams, prepare comprehensive regulatory packages, and monitor global regulatory...
$86k - $119.2k
Bio-Rad is looking for a Regulatory Affairs Specialist II to join our Irvine, CA office. In this position you will support new product developments/product modifications, IVDR implementation, and international product registrations. This position must be based in Irvine...Work at office- Regulatory Affairs Specialist Responsibilities Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions... ...acts as a resource for colleagues with less experience. Seniority Level Associate Employment Type Contract Job Function...Contract work
- ...and perspectives to the table, so we can truly know and help our clients, communities, and each other. CLA is looking to hire a Tax Senior to join our tax practice in the SoCal area! As a Tax Senior, you will: Prepare, supervise, and review individual, C corporation,...SeniorFull time
- An innovative defense technology company seeks a skilled firmware engineer to develop cutting-edge solutions for military applications. In this role, you will create low-level firmware for microcontrollers and integrate advanced technologies to enhance military capabilities...Senior
$130k - $180k
...manufacturing environments, our work sits at the intersection of engineering precision and real-world execution. We are looking for a Senior Electrical Commissioning Project Engineer who can lead from the front, solve complex technical challenges, and drive commissioning...SeniorContract workFor contractors- Anduril Industries' Maritime Division leads autonomy software for a maritime autonomous vehicle. You will own the autonomy software stack, covering system design, mission planning, perception, SITL/HITL testing, and development infrastructure. Reporting to the Mission ...Senior
- ...growing real estate financing organization that is looking to add a Senior Associate focusing on accounts payable processing including... ...activity. The company has adopted AI technology and l Accounts Payable, Specialist, Senior, Accounting, Vendor, Processing, Staffing...Senior
- A prominent healthcare provider in Irvine, California seeks a Physician Assistant for the Department of Surgery. The role involves managing and coordinating inpatient care for surgical patients, requiring clinical competence, excellent communication skills, and a current...Senior
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