Regulatory Affairs Specialist
ConsultNet Technology Services and Solutions
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, and contribute to regulatory submissions for agencies and customers. The role requires knowledge of 21 CFR QSR/cGMPs, ISO 13485, and experience with medical device regulations. #J-18808-Ljbffr
- ...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.Suggested
- ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided... ...team fit are paramount. The Principal Regulatory Affairs Specialist is a senior technical expert and strategic problem solver...SuggestedFull timeContract workRemote work3 days per week
- ...Regulatory Affairs Specialist This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including...SuggestedWork at office
- ...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...SuggestedImmediate 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...SuggestedWork experience placementLocal areaWorldwideFlexible hours$92k - $138k
...and other neurovascular conditions. The team partners across regulatory, quality, engineering, clinical, and commercial functions to... .... Travel is expected to be minimal.The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle management...Full timeH1bWork at officeLocal areaImmediate startFlexible hours- 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...
- 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
- 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...
- ...Regulatory Affairs Specialist (FDA, DEA) 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...
$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 lifecycle...Temporary workLocal areaFlexible hours- ...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...Work at office
- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-CA-Irvine; US-MN-Arden Hills; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance...Work at officeLocal areaRelocation3 days per week
- 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...
- ...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...
- ...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...
- Company DescriptionAt the dawn of the new millennium, a unique information technology company was born: HCL Technologies. As narrated in the video below, HCL Technologies has demonstrated remarkable growth through the recent economic downturn, emerging as one of only eight...
$110.1k - $183.4k
Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful opportunity to drive operational excellence, collaborate across global teams...Temporary workLocal areaFlexible hours- ...Embla Medical, a part of Össur, seeks a Compliance Specialist to support the Director of Compliance in managing the Americas compliance program across state and federal regulations and company code of conduct. Responsibilities include auditing, monitoring, training coordination...
- ...Westcliff University is seeking a Regulatory Specialist to manage regulatory compliance, accreditation, licensure, and related reporting across the university and affiliated institutions. You will coordinate documentation, ensure timely submissions, and work with academic...
$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 as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic...$80k - $95k
...Regulatory Affairs SpecialistThe Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities that support the company's worldwide medical device business. This position supports product registrations, regulatory submissions...Work at officeWorldwideWeekend workAfternoon shift$99.4k - $124.3k
...Compliance Specialist (Regulatory Change & Governance)Shaping the Future of LendingWith 30 years of fintech leadership, Origence empowers credit... ..., risk management, project management, regulatory affairs, operations, financial services, fintech, SaaS, lending, or...Full timeLocal area- ...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...
$84k - $85k
...and attend affordable and LIHTC audits performed by state and regulatory agencies. Review applications and determine eligibility for the... ...of Affordable Multi‑Housing experience. Certified Occupancy Specialist or similar certifications are required. 2 years’ experience in...Contract workLocal areaImmediate start- ...assist in the implementation and maintenance of the bank's compliance program. You will be responsible for monitoring and analyzing regulatory requirements, internal policies, and industry standards to ensure the bank operates in adherence to applicable laws and...Work at office
- ...support Prepare on demand reports and SKU lists for Compliance Specialists and Management Review and upload approved classification data... ...determined by Supervisor Administrative support for required regulatory reporting requirements in a timely manner. Export Control...Immediate startFlexible hours
$61.12k - $95.39k
...& Supports solutions. Helping people live a Life Without Limitations is why we exist as a company. About the Role The Compliance Specialist is responsible for assisting the Director of Compliance in the management of the compliance program for Embla Medical’s Americas...Full timeWork experience placementLocal areaWorldwide$25 per hour
...opportunities.We are seeking an experienced Labor Compliance Specialist to join our team. The ideal candidate will have 3–5 years of California... ...and maintain labor compliance documentation, reports, and regulatory filings.Ensure compliance with contractual obligations,...Hourly payContract workApprenticeshipFor subcontractorWork at officeLocal area$70k - $90k
...Compliance Specialist CopperPoint has an exciting opportunity for a Compliance Specialist. In this role, you'll help develop and administer an effective regulatory compliance program that ensures adherence to state regulatory and statutory requirements. You'll research...Hourly payTemporary workFlexible hours
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