Global Regulatory Affairs Specialist for FDA Submissions
PRISMATIK DENTALCRAFT, INC.
Prismatik Dentalcraft, a division of Glidewell Dental, is seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. You will lead FDA 510(k)/PMA filings, maintain international registrations, support audits, and develop SOPs while partnering with technical teams to ensure products meet regulatory standards. The role requires interpreting regulations, managing complex documentation, and guiding teams through compliance #J-18808-Ljbffr PRISMATIK DENTALCRAFT, INC.
- ...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... .... The successful candidate will manage FDA 510(k) submissions, monitor regulatory...Suggested
- ...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...Suggested
$92k - $138k
...here. Medtronic is a global leader in healthcare... ...team partners across regulatory, quality, engineering... ...The Senior Regulatory Affairs Specialist supports regulatory compliance... ...preparing regulatory submissions, maintaining... ...Drug Administration (FDA) medical device submissions...SuggestedFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...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 an...Suggested
- ...Regulatory Affairs Specialist (FDA, DEA)The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare... .... This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying...Suggested
- ...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...
- ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual... ...Regulatory Affairs Specialist is a senior technical expert... ...the execution of key U.S. FDA submissions—including IDEs, 510(k)s, and... ...ensuring alignment across global stakeholders and timelines....Full timeContract workRemote work3 days per week
- ...Senior Regulatory Affairs SpecialistAt Boston Scientific, we... ...Senior Regulatory Affairs Specialist position (hybrid work... ...Affairs support of submissions and ongoing... ...partnership with our global R&D, manufacturing, clinical... ...Working knowledge of FDA, EU and international...Work at officeLocal area3 days per week
$76k - $121.9k
...Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular.... ...will support preparation, submission, tracking, indexing, and archiving... ...work closely with other Global Regulatory Affairs partners... ...product information to US FDA, EU Notified Bodies, and...Temporary workLocal area$120k - $155k
...Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies. About the Role Qnovia is advancing a... ...United Kingdom. As a Regulatory Affairs Specialist, you will develop and execute regulatory...Local areaFlexible hours$95.8k - $159.6k
...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical... ...market while ensuring compliance with global regulatory requirements. In this... ...you will support regulatory strategy, submissions, and product lifecycle activities across...Temporary workLocal areaFlexible hours$110.1k - $183.4k
...Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse... ...determine regulatory classification, jurisdiction, submission requirements, and approval pathways. Assess regulatory...Temporary workLocal areaFlexible hours- Regulatory Affairs Specialist (Labeling) Contract through May 2026 - NO C2C, W2 ONLY. A leading medical... ...Affairs Specialist to support global and EU labeling compliance across a... ...product development, sustaining projects, submissions, and manufacturing transfers Ensure...Contract work
- ...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, support audits...
- ...Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and... ...of documentation for medical device submissions and effectively communicate regulatory... ...years working in a regulated industry (FDA and Software as a Medical Device...
$95.8k - $159.6k
...Hybrid or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused... ...market while ensuring compliance with global regulatory requirements. In this role,... ...you will support regulatory strategy, submissions, and product lifecycle activities across...Full timeFor contractorsLocal area$85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful... ...Notifications and other types of regulatory submissions.Manage international and domestic... ...and establishment registrations with FDA.Maintain regulatory databases and...Work experience placementLocal areaWorldwideFlexible hours- ...is responsible for the preparation of regulatory submissions required to market medical devices in both... ...registrations and related regulatory affairs activities, including execution of procedures... ...of industry consensus standards and FDA guidance is required At least 2 years...Work at office
- ...Functions Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device... ...Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international...
- ...Regulatory Affairs Specialist Responsibilities Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions for products that require government approval. Demonstrates working knowledge of healthcare-related regulations. Demonstrates...Contract work
$80k - $95k
...available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating... ...registrations, regulatory submissions, approvals, and post-market... ...and Responsibilities Global Product Registrations and Regulatory... ...submissions, including FDA 510(k) submissions and...Work at officeWorldwideWeekend workAfternoon shift$90k - $140k
...Regulatory Strategy Lead Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve... ...proteomic biomarkers. Ensure alignment with FDA expectations for Breakthrough Device Designation...- ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports... ...reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs. Perform research to...Immediate start
$83.9k - $120k
...Functions Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device... ...85 Standards. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg...- ...is a leader in innovative global education. We are respected... ...grow and succeed together! Regulatory Specialist Job Summary The Regulatory... ...Coordinate the preparation, submission, and maintenance of accreditation... ...effectiveness, regulatory affairs, or a related field....Work at office
- ...seeking a labeling professional to design, develop and update global labeling documents including product labels, IFUs, implant cards... ...labels and templates, ensure labeling compliance with QMS and regulatory guidelines, and coordinate with suppliers for outsourced materials...
$90k - $120k
...Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington... ...compliance with global regulatory requirements... ...compliance with: EU MDR FDA QSR ISO 13485 / MDSAP... ...Technical Documentation submissions for the EU, MDSAP...Full time- ...similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project... ...within the IVD industry. Knowledge of FDA, and CE marking requirements for IVD products... .... Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
$85.8k - $137.3k
...is a leading technology company for the global information technology ecosystem. With the... ...reports and SKU lists for Compliance Specialists and ManagementReview and upload approved... ...SupervisorAdministrative support for required regulatory reporting requirements in a timely...Full timeTemporary workImmediate startWorldwideFlexible hours- ...implementation of US and Canada regulatory strategic and tactical... ...defined within the Global Regulatory Product... ...Health Authority (FDA) for key projects/issues... ...including Public Affairs, Clinical Development,... ...review of regulatory submissions consistent within US and...Full timeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist for FDA Submissions. Be the first to apply!
- regulatory affairs specialist Irvine, CA
- medicare compliance specialist Irvine, CA
- senior compliance analyst Irvine, CA
- regulatory compliance analyst Irvine, CA
- compliance specialist Irvine, CA
- aml compliance analyst Irvine, CA
- regulatory officer Irvine, CA
- healthcare compliance officer Irvine, CA
- regulatory analyst Irvine, CA
- regulatory specialist Irvine, CA


