Global Regulatory Affairs Specialist - Medical Devices
Baxter
Baxter is seeking a Principal Specialist, Global Regulatory Affairs to lead regulatory activities for a portfolio of medical device products across the U.S., EU, and global markets. You will develop strategies, assess changes, and support submissions to maintain market access and compliance throughout the lifecycle. Working with Regulatory Affairs, R&D, Quality, Marketing, and Operations, you will guide regulatory input for sound business decisions and lifecycle management. #J-18808-Ljbffr
- ...Baxter Healthcare is seeking a Principal Specialist, Global Regulatory Affairs to lead regulatory activities for a portfolio of medical device products in the U.S., EU, and globally. You will craft regulatory strategies, assess changes, and support submissions that maintain...Medical device
- Baxter International Inc. in Round Lake, IL is seeking a Principal Specialist, Global Regulatory Affairs. You will manage regulatory approvals, registrations, and change assessments for medical device products across the US, EU, and other markets, shaping submission strategies...Medical device
$104k - $143k
...a job—you will find purpose and pride. Your role at BaxterAs a Principal Specialist, Global Regulatory Affairs, you will manage regulatory activities for an assigned portfolio of medical device products across the U.S., EU, and other global markets. You will develop regulatory...Medical deviceFull timeTemporary workWork visaFlexible hours$80.9k - $127.05k
...Principal Regulatory Affairs SpecialistRegulatory provides regulatory... ...pharmaceutical, medical and biotechnology... ...Principal Regulatory Affairs Specialist supports the Medical... ..., developing global regulatory strategies... ...regulatory and medical device requirements.Monitor,...Medical deviceTemporary workWork experience placementLocal areaImmediate startRemote work$104k - $143k
...job—you will find purpose and pride. Your role at Baxter As a Principal Specialist, Global Regulatory Affairs, you will manage regulatory activities for an assigned portfolio of medical device products across the U.S., EU, and other global markets. You will develop regulatory...Medical deviceTemporary workWork visaFlexible hours$78k - $156k
...HealthcarePosted Date: 2026-08-06Abbott is a global healthcare leader that helps people... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...information on the IT Compliance needs and regulatory environment.What You’ll Work OnLeads the...Medical deviceWorldwide$112k - $154k
...years of relevant industry experience.Medical device industry experience is preferred.Requires... ...Strong knowledge of ISO, FDA and other regulatory standards is essential.Knowledge of... ...accommodations to individuals with disabilities globally. If, because of a medical condition or...Medical deviceFull timeTemporary workWork visaFlexible hours- ...train our internal team on regulatory requirements, data collection... ...Finance, Sales, Marketing, Medical Affairs, Accounts Payable, Procurement... ...working in the medical device, pharmaceutical, biotechnology... ...Experience working in a global medical device or pharmaceutical...Medical deviceTemporary work
- ...system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities... ...activities comply with applicable quality standards, regulatory requirements, and internal procedures. Collaborate with cross...Medical device
$168k - $231k
...at the forefront of innovation in the medical device industry, dedicated to improving patient... ...on software development and validation.Regulatory Knowledge: Demonstrate strong knowledge... ...accommodations to individuals with disabilities globally. If, because of a medical condition or...Medical deviceTemporary workLocal areaRelocation packageFlexible hours- ...Prairie, WI, seeks a Senior International Trade Compliance Specialist to tackle regulatory hurdles and find tariff savings for international... ...classifications and leading compliance programs to support global operations. Ideal candidates have a Bachelor's degree and...
- ...Monitors activity in COSMOS (Regulatory Information Management solution... ..., biology, chemistry, medical technology pharmacology) Required... ...years in pharmaceutical, medical device or healthcare related field... ...: 0-2 years in Regulatory Affairs or Regulatory Operations role...Medical device
$113.3k - $226.7k
What You’ll Work On Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of... ..., with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues...Medical deviceWorldwide$165k - $230k
Associate Director, Global Quality and Compliance Excellence BioSpace... ...issues today and address the medical challenges of tomorrow. We... ...to lead preparedness for regulatory inspections and audits at AbbVie... ...combination products, medical devices, tissue, and cosmetics for...Medical deviceFull timeTemporary workLocal area- ...Monitors activity in COSMOS (Regulatory Information Management solution... ..., biology, chemistry, medical technology pharmacology) Required... ...years in pharmaceutical, medical device or healthcare related field... ...: 0-2 years in Regulatory Affairs or Regulatory Operations role...Medical deviceFor contractors
$62k - $105k
...Department : Quality Summary The Sr. Global QMS Documentation and Records Control Specialist is responsible for managing the... ...is essential for ensuring that medical device products are designed,... ...during internal audits and external regulatory inspections (e.g., FDA,...Medical deviceWork at officeWorldwide$168k - $231k
...work saves lives. As Technical Specialist, lead the development and execution... ...software activities across the global corporation’s medical devices, products, and applications. Be an... ...Monitor current security industry and regulatory trends to prepare organization for...Medical deviceTemporary workLocal areaWork visaRelocation packageFlexible hours- ...integration, risk assessment, and system validation for innovative drug/device combos. You will lead global engineering activities, collaborate with external partners, and ensure designs meet IEC/ISO and regulatory requirements while delivering robust patient-centric solutions....Medical device
- ...WI seeks an International Trade Compliance Specialist to navigate import/export regulations and identify tariff savings for global shipments. You will review product... ...brokers and agencies, and help implement regulatory processes. Strong organizational and communication...
- ...and a minimum of 8 years of quality experience in pharma or medical device manufacturing. Key responsibilities include writing and maintaining... ...North Chicago, providing critical support to ensure compliance with corporate and regulatory standards. #J-18808-Ljbffr SPECTRAFORCEMedical device
- ...role focuses on planning, assigning projects, and delivering high-quality media resources. Candidates with management experience in scientific/medical devices and strong MS Office/PM tool skills are preferred. Travel about 15% is required. #J-18808-Ljbffr Sysmex AmericaMedical device
- ...improve patient outcomes through cross‑functional collaboration on medical device development. You will guide design inputs and interface... ...decompose complex system needs while aligning with quality and regulatory standards. The role requires a strong background in systems...Medical device
- ...and the department is following regulatory compliance requirements.... ...uses in projected products or devices. Qualifications • Knowledge of cGMP and global regulatory guidelines such as EMA... ...the pharmaceutical industry or medical device experience • BS in Science...Medical device
$60 - $63 per hour
Regulatory Affairs Associate III - Regulatory Process Excellence, CAPA Management & Inspection Readiness... ...: $60-63/hr (depending on candidate medical benefits preference) Job Description:... ...within the pharmaceutical, medical-device, or regulatory industry. Experience in...Medical device- ...-08-17Baxter International Inc. seeks a Quality Associate II within the Quality organization to uphold audit quality systems and regulatory compliance. You will manage internal audits, CAPA, inspections readiness, and mentor junior staff while driving continuous improvement...Medical deviceWorldwide
$31 - $33 per hour
...such as Pharmacy, Biology, Chemistry, Medical Technology, Pharmacology, or a related... ...experience within the pharmaceutical, medical device, biotechnology, or healthcare industry.... ...or academic/internship exposure to Regulatory Affairs, Regulatory Operations, or regulatory...Medical deviceInternshipWork at office$120k - $165k
...ensures sustained product performance, regulatory compliance, cost optimization, and timely... ...of changes in a highly regulated medical device environment.The role serves as the single... ...Proven ability to drive cross-functional global teams within electromechanical medical...Medical deviceFull timeTemporary workLocal areaWork visaFlexible hours$104k - $143k
...cybersecurity design and analysis of multiple medical devices. Demonstrate subject matter expert... ..., Compliance, Clinical, Human Factors, Regulatory, Marketing, Service).Ensure compliance... ...to individuals with disabilities globally. If, because of a medical condition or...Medical deviceFull timeTemporary workWork visaFlexible hours3 days per week$232k - $319k
...driving innovation across the medication delivery continuum, from... ...functional teams, including regulatory affairs, quality assurance and clinicians... ...background in medical device systems and a track record of... ...:The role is located at our global corporate headquarters in the...Medical deviceFull timeTemporary workRelocation packageFlexible hours3 days per week$96k - $132k
...will support the development activities for complex medical devices that meet customer needs and regulatory standards. This role works with talented systems,... ...reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability,...Medical deviceFull timeTemporary workLocal areaWork visaFlexible hours
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