Senior Regulatory Affairs Specialist
BioSpace, Inc.
AbbVie is seeking a Senior Associate, RA CMC to manage post-approval variation activities, author CMC sections, and coordinate with regulatory and cross-functional teams to ensure timely submission documents. The role includes project management, content planning, and ensuring CTD conformity. The position requires a BA/BS in Chemical or Biological sciences and 4+ years in pharma, including quality systems or cross-functional project management, with strong communication skills and ability to #J-18808-Ljbffr
$92k - $148.35k
...our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category... ...more at are searching for the best talent for a Senior Regulatory Affairs Specialist. This role will work a Hybrid/Flex schedule with 3 days...SeniorFull timeContract workTemporary workLocal areaImmediate startFlexible hours3 days per week- ...Senior Regulatory Affairs SpecialistWork mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-CA-Irvine; US... ...an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing...SeniorWork at officeLocal areaRelocation3 days per week
- ...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
- 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
$95.8k - $159.6k
Work Flexibility: Hybrid or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy...SeniorFull timeFor contractorsLocal area$66.1k - $118.3k
...we have 260,000 smart people working to make that happen. As a Senior Compliance Analyst with us, you will monitor changes to laws and... .... You will be responsible for monitoring internal and external regulatory audits. And you will be expected to monitor changes in...SeniorWork experience placementLocal areaRemote work$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- ...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
$122k - $212.75k
...are searching for the best talent for a Senior Manager, Health Care Compliance Officer... ...potential concerns.Monitor changes in the regulatory and healthcare compliance environment... ...Compliance, Legal, Privacy, Government Affairs, Human Resources, Finance, Regulatory Affairs...SeniorFull timeLocal areaImmediate start- ...able to come to the office in Irvine, CA on in office days and as needed to carry out necessary functions of the role. The GRC Senior Regulatory Compliance Analyst, who has proficient knowledge in regulatory compliance rules and regulations will be responsible for...SeniorContract workWork at office
- ...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
$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$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- 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
$92k - $138k
...other neurovascular conditions. The team partners across regulatory, quality, engineering, clinical, and commercial... ...regulatory activities. Travel is expected to be minimal. The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle...SeniorFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...you ready to join us?This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance... ...Regulatory Affairs Strategy (Professional Path) , reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily...SeniorHourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...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- ...Senior Compliance SpecialistThe Boeing Company's Law and Global... ...seeking a Senior Compliance Specialist to join our Compliance Risk Management... ..., and reports on key legal, regulatory and policy risks across the... ..., investigations, regulatory affairs, audit, law, or related...SeniorWork at office3 days per week
- ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the... ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
- ...Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S... ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems...Work at office
$63.44k - $96.72k
...Sr. Regulatory Compliance SpecialistLocation: Irvine, CA, US, 92618 Employment Type... ...: Remote Position Summary: The Senior Regulatory Compliance Specialist is responsible for supporting the implementation... ...compliance, or in a regulatory affairs capacity Ability to travel 5%...SeniorWork at officeLocal areaRemote work- ...A global technology firm is seeking an experienced Data Scientist / Senior Consultant to drive the strategy and execution of their search and recommendation systems. The ideal candidate will possess a Master’s or Ph.D. in a quantitative field and over a decade of relevant...Senior
- ...Description Job Description HIGH-LEVEL OVERVIEW The Senior Trade Compliance Specialist is responsible for ECCN and HTS classification of... ...flows, and FAQs · Conduct compliance audits and prepare regulatory reporting · Prepare metrics, KPIs, and reporting on classification...Senior
- ...Edwards Lifesciences is seeking a Senior Manager to bridge Corporate Finance (FP&A) and advanced analytics. The role builds and operationalizes statistical forecasting and scenario models to improve planning accuracy, partnering with Finance leaders to enable this capability...Senior
- Orange Unified School District in Costa Mesa, CA invites applications for an administrative leadership role. Candidates must hold an Administrative Services Credential (copy required), a masters degree or higher (transcripts required), and preferably a Doctorate. Four years...SeniorInternship
- Terran Orbital in Irvine is seeking an experienced Flight Software Engineer to drive embedded C++ for high‑performance spacecraft systems and lead software development across simulation, flight hardware, and payloads. You will report to the Flight Software Engineering...SeniorRemote work
$110.1k - $183.4k
Work Flexibility: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful...Full timeFor contractorsLocal area- Completed Ed Join OUSD Certified Management Application * Letter of Introduction addressed to Dr. Matthew Witmer, Ed.D., Assistant Superintendent, Educational Services * Current Resume * Three Letters of Recommendation (dated within 2 years of the job posting, with a wet...SeniorInternshipSecond job
- ...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
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