Global Regulatory Affairs Specialist - Medical Devices
Nihon Kohden OrangeMed, LLC
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, collaborate with internal teams, sales offices, distributors, and regulatory partners, and escalate complex issues as needed while ensuring compliance throughout the product lifecycle. #J-18808-Ljbffr
- ...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...Medical device
- ...Ormco is seeking a Regulatory Affairs Specialist to drive global product registrations, maintain regulatory filings, and align with EU MDR requirements... ...role requires 2+ years in regulatory affairs for medical devices or regulated industries, with strong CER/SSCP/PSUR experience...Medical device
- ...Jenavalve Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong focus on managing regulatory communication... ...submissions. The role requires substantial experience in medical device regulations, ensuring compliance with quality standards...Medical device
$80k - $95k
...positions become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and... ...support the company’s worldwide medical device business. This position supports... ...appropriate. Duties and Responsibilities Global Product Registrations and Regulatory...Medical deviceWork at officeWorldwideWeekend workAfternoon shift$92k - $138k
...here. Medtronic is a global leader in healthcare... ...developing innovative medical technologies that improve... ...team partners across regulatory, quality, engineering... ...Senior Regulatory Affairs Specialist supports regulatory... ...neurovascular medical devices. This role is responsible...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Scientific is partnered with an established medical device innovator developing life-changing technologies... .... As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions,...Medical device
$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... ...Kingdom. As a Regulatory Affairs Specialist, you will develop... ...pharmaceutical or medical device industry...Medical deviceLocal areaFlexible hours- ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual... ...Regulatory Affairs Specialist is a senior technical expert... ...for Class III cardiovascular medical devices. In this highly visible... ...ensuring alignment across global stakeholders and timelines....Medical deviceFull timeContract workRemote work3 days per week
$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,... ...Experience working with medical devices or other regulated healthcare...Medical deviceTemporary workLocal areaFlexible hours- Regulatory Affairs Specialist (Labeling) Contract through May 2026 - NO C2C, W2 ONLY. A leading medical device team is seeking a Regulatory Affairs Specialist to support global and EU labeling compliance across a wide range of projects. What You’ll Do: Own regulatory...Medical deviceContract work
$76k - $121.9k
...Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular. At... ...regulatory activities to obtain and maintain medical device approvals/clearances in the US and... ...will work closely with other Global Regulatory Affairs partners and with...Medical deviceTemporary workLocal area$110.1k - $183.4k
...Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse... ...years of regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related regulated...Medical deviceTemporary workLocal areaFlexible hours$85.8k - $104.8k
The Regulatory Affairs Specialist creates, evaluates and completes regulatory tasks related to worldwide... ...is responsible for obtaining global regulatory registrations/approvals based... ...of Regulatory Affairs experience in medical devices or other regulated industry. We will...Medical deviceContract workWork at officeWorldwideFlexible hours$89.2k
...Diversity - Innovation - Caring - Global Collaboration - Winning... ...individual for a Senior Regulatory Affairs Specialist position (hybrid work mode)... ...growing active implantable device portfolio. This role will be... ...Affairs experience in the medical industry Prior experience with...Medical deviceHourly payWork at officeLocal areaRelocationShift work3 days per week$90k - $120k
...Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington Beach, CA... ...safe, reliable, and innovative medical devices that improve patient outcomes.... ...critical in ensuring compliance with global regulatory requirements and...Medical deviceFull time- Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...Medical device
- ...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 of procedures and systems...Medical deviceWork at office
$95.8k - $159.6k
...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... ...working with medical devices or other regulated healthcare...Medical deviceFull timeFor contractorsLocal area$185k - $240k
A leading medical device company located in California is seeking a Director of Global Commercial Training. The role involves directing and overseeing commercial employee training programs to enhance effectiveness and ensure onboarding support. Candidates should possess...Medical device- ...Lifesciences in Irvine, CA, seeks a Senior Product Manager, Global Training for the Global Marketing team. The role focuses on developing... ...launches. This on-site position requires experience in medical devices and education strategy within a global context. As the SME...Medical device
- 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...
$85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory... ...capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory...Medical deviceWork experience placementLocal areaWorldwideFlexible hours- ...Regulatory Affairs Specialist (FDA, DEA)The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare... ...and state regulations related to pharmaceuticals, medical devices, and controlled substances.Key ResponsibilitiesPrepare and...Medical device
$144.3k - $176.3k
Job Description:The Sr. Global Product Manager is responsible for defining and driving... .... Leads cross-functional teams (R&D, Regulatory, Marketing, Operations, Finance) to deliver... ...product management experience in the medical device or regulated industry preferred.Proven...Medical deviceFull timeContract work- ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies,... ...Quality System Standard. Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations...Medical deviceImmediate start
- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company developing... ..., and providing oversight for medical device programs. This role requires a seasoned... ...a strong background in regulatory affairs, particularly within the biotechnology...Medical device
- ...champion progress, and act swiftly to impact global eye health. We foster an inclusive... ...role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products... ...to drive competitive advantageSupport medical device and/or pharmaceutical products,...Medical deviceHourly payTemporary workLocal areaRelocation packageFlexible hours
- Please find below the JD for the role of Regulatory Affairs Strategy Associate at Lake Forest, CA. Regulatory Affairs Strategy Associate... ...timely submissions and approvals. Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant...Medical deviceLocal area
$61.12k - $95.39k
...Us Össur is a leading global provider of innovative mobility... ...the Role The Compliance Specialist is responsible for assisting... ...compliance program for Embla Medical's Americas Business Units. This... ...that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal area$130k - $190.2k
Job Description:Position Summary: The Global Product Manager is responsible for the complete product lifecycle management of assigned... ...required in a highly regulated industry, preferably in the medical device or dental industry. Experience working through distribution as...Medical deviceFull timeContract workWork experience placementWork at office
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