Global Regulatory Affairs Specialist - Medical Devices
Nihon Kohden Orange Med
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 requirements. The successful candidate will manage FDA 510(k) submissions, monitor regulatory changes, and provide support for post‑market activities, labeling, and compliance throughout the product lifecycle. #J-18808-Ljbffr
- ...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
...Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and executing routine... ...support the company's worldwide medical device business. This position supports product... ...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- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough... ...- Innovation - Caring - Global Collaboration - Winning... ...growing active implantable device portfolio. This role will be... ...Affairs experience in the medical industry Prior experience...Medical deviceWork at officeLocal areaRelocation3 days per week
- ...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
$76k - $121.9k
...merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...for a Regulatory Affairs Specialist II , MedTech Neurovascular... ...activities to obtain and maintain medical device approvals/clearances in the... ...work closely with other Global Regulatory Affairs partners...Medical deviceTemporary workLocal area$85.8k - $104.8k
...R5026645 Job Description: The Regulatory Affairs Specialist creates, evaluates and completes regulatory... ...is responsible for obtaining global regulatory registrations/approvals... ...of Regulatory Affairs experience in medical devices or other regulated industry. We will...Medical deviceFull timeContract workWork at officeWorldwideFlexible hours$110.1k - $183.4k
...Staff International Regulatory Affairs Specialist Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly... ...affairs experience within the medical device, biotechnology, pharmaceutical, or...Medical deviceTemporary workLocal areaFlexible hours- 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
$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- ...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 payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...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
$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$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- ...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 Responsibilities...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
- 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
$144.3k - $176.3k
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$40 - $46 per hour
Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated... ...Industries This is an exciting opportunity to join a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to...Medical deviceHourly pay$185k - $240k
...Responsibilities / Competencies Director of Global Commercial Training directs and... ...e. marketing, sales managers, clinical specialists, etc.) to close skills, knowledge, technical... ...in a commercial training role. Medical Device Experience Required. Sales experience...Medical deviceShift work$173k - $245k
...heart. Edwards Lifesciences is the leading global structural heart innovation company,... ...strengthen operational excellence and regulatory adherence. Oversight and management of... ...working in Healthcare Compliance in a large Medical Device, Pharmaceutical, and/or Biotech company...Medical deviceFull timeWork experience placementLocal area$61.12k - $95.39k
About 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... ...regulations that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal areaWorldwide$19 - $21 per hour
...Now Hiring Medical Device Assemblers Location: Irvine, CA Pay: $19-21/hr Shifts Available: Monday- Friday 6am- 3pm Monday-... ...and perform repetitive tasks Why This Position? Work for a global leader in medical technology Clean, climate-controlled manufacturing...Medical deviceWeekly payContract workTemporary workImmediate startWorldwideMonday to FridayShift workNight shift$182k
...building a deep understanding of the global market landscape, trends, customer... ...relationship with leaders across R&D, regulatory/legal, medical affairs, market research, operations,... ...experience in pharmaceuticals or medical devices, with experience in medical aesthetics...Medical deviceTemporary workLocal area$128.3k - $156.8k
...dynamic, strategic, and results-oriented Global Sr. Manager, Procurement to lead and... ...operations across a growing global medical device organization.This leader will develop... ...collaborate closely with Operations, Quality, Regulatory Affairs, R&D, Engineering, Finance, and...Medical deviceFull timeContract workWork at office$120k - $140k
...20% About Kardion Kardion is a medical device company advancing innovative technology... ...headquarters in Irvine and strengthen our global operating model, we are seeking a... ...cross-functional partners in Quality, Regulatory, Clinical, R&D, Finance, and other teams...Medical deviceFull time
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