Regulatory Specialist
Denken Solutions
Hybrid role Job Description:
About us:
At our organization, we take our mission and values to heart! We are on a mission to offer more and better jobs all over the world! Our goal is to care for you while you care for our clients and get you paid the highest pay possible. All our associates working with us are expected to embrace our RACE values: R - Results Matter, A- Approachable, C - Care, and E - Emergency i.e. work with a sense of urgency.
For more relevant job opportunities please visit our website: Denken Solutions Careers
- Work Location: Holbrook, NY / Hybrid
- Work Schedule: FT / Mon-Fri 9 am - 5 pm
- Managing technical queries and documentation via RDM.
- Coordinating registration dossiers through Polaris, collaborating cross-functionally, and maintaining data trackers for visibility.
- Applying for Certificates of Free Sale (FDA, NY Chamber, NJDHHS, etc.) and dispatching them.
- Dispatching finished product samples for registration requirements.
- Handling notarization/legalization for approvals and managing document collection and dispatch to markets.
- Liaising with Co Mans and suppliers for essential information.
- Supporting priority projects in 2026/2027 (e.g., Navigate, Project MAX).
- Bachelors Degree in Regulatory Affairs or related field.
About us:
At our organization, we take our mission and values to heart! We are on a mission to offer more and better jobs all over the world! Our goal is to care for you while you care for our clients and get you paid the highest pay possible. All our associates working with us are expected to embrace our RACE values: R - Results Matter, A- Approachable, C - Care, and E - Emergency i.e. work with a sense of urgency.
For more relevant job opportunities please visit our website: Denken Solutions Careers
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Specialist in Irvine, CA vacancy
$60 per hour
...Take your regulatory affairs expertise to the next level with an opportunity to support innovative diagnostic products on a global scale... ...:00 PM Why This Role Matters As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic products meet...SuggestedHourly payTemporary workMonday to FridayManpower
Irvine, CA20 hours ago- ...Management within the IVD industry. ~ Knowledge of FDA, and CE marking requirements for IVD products is preferred. ~ Excellent verbal and written communication skills. ~ Thorough knowledge of policies, practices and procedures related to Regulatory Affairs....Suggested
Katalyst HealthCares & Life Sciences
Irvine, CA1 day ago - ...Responsibilities: 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 execution...SuggestedWork at office
Katalyst Healthcares and Life Sciences
Irvine, CA4 days ago $60 per hour
...Regulatory Affairs Specialist Our client, a leading organization in the medical device and diagnostics industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs department...SuggestedHourly payTemporary workMonday to FridayShift work- ...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...SuggestedWork at officeLocal area3 days per week
Intracept by Boston Scientific
Irvine, CA20 hours ago - ...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
Diality
Irvine, CA4 days ago - ...Regulatory SpecialistThe Regulatory Specialist supports regulatory compliance, accreditation, authorization, and licensure activities for Westcliff University and its related institutions. This position assists in securing approvals and maintaining compliance with institutional...Work at office
Westcliff University
Irvine, CA4 days ago - ...Regulatory Affairs Specialist 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...
Katalyst HealthCares & Life Sciences
Irvine, CA3 days ago $110.1k - $183.4k
...Staff International Regulatory Affairs Specialist 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...Local areaStryker
Irvine, CA1 day ago$80k - $95k
...Job Purpose The 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, approvals,...Work at officeWorldwideWeekend workAfternoon shiftNihon Kohden Orange Med
Santa Ana, CA4 days ago$90k - $140k
...Regulatory Strategy Lead For AI/ML-Based SaMD Product 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...PreludeDx
Laguna Hills, CA3 days ago$32 - $36 per hour
...Regulatory Affairs Associate Location: Tustin, CA Schedule: Monday–Friday, 9:00 AM–5:00 PM Pay: $32–$36 per hour, based on experience and qualifications Employment Type: Temporary-to-Hire A growing biotechnology company in Tustin is seeking a Regulatory Affairs...Hourly payTemporary workWork at officeMonday to FridayPrideStaff
Tustin, CA4 days ago$120k - $155k
...Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory... ...the United States and United Kingdom. As a Regulatory Affairs Specialist, you will develop and execute regulatory strategies, prepare...Local areaFlexible hoursQnovia, Inc.
Newport Beach, CA1 day ago- ...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
CommerceWest Bank
Irvine, CA2 days ago $38.46 - $40.87 per hour
...THIS POSITION WILL BE LOCATED IN WILIMINGTON, CA 90744 Ensure compliance with LIHTC, HUD, and other owner, investor, lender, and regulatory agency requirements. Audit move‑in, recertification, and eligibility files; prepare and submit required compliance reports; track...Hourly payFull timeWork at officeMonday to FridayFlexible hoursWSH MANAGEMENT INC
Irvine, CA2 days ago$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 area2020 Companies
Irvine, CA1 day ago$99.4k - $124.3k
...Compliance Specialist (Regulatory Change & Governance)Shaping the Future of LendingWith 30 years of fintech leadership, Origence empowers credit unions with innovative SaaS lending solutions that make lending more accessible, efficient, and competitive. We invest in our...Full timeLocal areaOrigence
Irvine, CA20 hours ago$23 - $25 per hour
...attention to detail, and the ability to identify risks, recommend practical solutions, and support a culture of accountability, regulatory readiness, and continuous improvement. About Us At Alleviate Financial Solutions , we’re transforming lives every day by offering...Hourly payFull timeFixed term contractWork at officeLocal areaMonday to FridayShift workAlleviate Financial Solutions
Irvine, CA4 days ago- Compliance CoordinatorThe Compliance Coordinator is responsible for the accurate creation, tracking, and submission of fire life safety inspections, repairs, and retest reports. This role ensures all required documentation is complete, compliant, and delivered to customers...Hourly payWeekend work
Commercial Fire Protection
Irvine, CA20 hours ago $68k - $75k
...Regulatory Affairs Associate Zymo Research is looking for a motivated individual to join our Regulatory Affairs team! In this role, you will play a vital part in supporting regulatory activities and maintaining compliance with applicable requirements, utilizing your...Local areaImmediate startFlexible hours- ...prioritize works efficiently and effectively Experience with OneTrust Security-related certifications (CISA, CISM, CISSP, SANS GIAC) Higher education and/or research institution experience Understanding of higher education legal and regulatory environment (e.g....Remote work
Samprasoft
Irvine, CA4 days ago - ...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...
Nihon Kohden Orange Med
Santa Ana, CA1 day ago - ...activities related to field alerts, market action decisions, and related corrective activities. # Participate and take active role in regulatory inspections and communications. # Work with subject matter experts to keep the site inspection-ready, organizing resources and...
Aequor Inc
Irvine, CA3 days ago - ...University of California, Irvine Health is seeking an experienced Senior Credentialing Specialist to coordinate credentialing and privileging activities for the Medical Staff Administration Department. The role requires analyzing applications, ensuring compliance with...
University Of California Irvine
Irvine, CA20 hours ago - 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...
University Of California Irvine
Irvine, CA3 days ago - ...policies, processes, and resources. The Senior Credentialing Specialist serves as an essential link and resource between department senior... ...compliance with organizational policies and accrediting and regulatory standards. Responsible for meeting management to the...Monday to Friday
University Of California Irvine
Irvine, CA20 hours ago $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...Full timeLocal areaStryker
Irvine, CA22 days ago- Licensed Loan Officer All In Bound Leads | No Cold Calling | Make Great Money | Have a Career Do you have your NMLS CA-DOC license? Do you have at least one year of experience selling home loans? Would you like to build a career with a stable and financially ...Work at officeImmediate 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...Work experience placementLocal areaWorldwideFlexible hours- ...compliance with contract obligations. You will interact with internal teams and customers, contributing to proposals and demand planning as needed. The role reports to the Contracts Manager and requires strong analytical, regulatory, and communication skills. #J-18808-Ljbffr...Contract work
Parker Hannifin Corporation
Irvine, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Specialist. Be the first to apply!
Related searches
- compliance analyst Irvine, CA
- regulatory compliance specialist Irvine, CA
- regulatory affairs specialist Irvine, CA
- legal compliance analyst Irvine, CA
- regulatory compliance associate Irvine, CA
- cybersecurity policy and compliance analyst Irvine, CA
- compliance specialist Irvine, CA
- coding compliance specialist Irvine, CA
- compliance consultant Irvine, CA
- compliance associate Irvine, CA