Global Regulatory Affairs Specialist
Virtual Vocations Inc
Seeking a remote, 12-month contract Global Regulatory Affairs Specialist, the candidate will coordinate and support the maintenance of labeling intelligence, ensuring compliance and alignment with business needs while managing label tracking strategies throughout the product lifecycle. Key responsibilities Coordinate the labeling universe maintenance process, including analysis and tracking of updates Implement label tracking strategies and manage end-of-label maintenance activities Perform regular data quality checks and support the resolution of identified issues Required qualifications Bachelor's Degree or equivalent; advanced academic qualification/degree preferred 8+ years of experience in a global/multi-national pharmaceutical environment, specifically in Labeling or Regulatory Affairs Experience with labeling intelligence systems such as PfLEET, GDMS, or PEARL Proficiency in Business Analytics and experience working in a matrix team environment Knowledge of global and local regulatory guidance around labeling and associated documentation
- ...AirClean Systems in Brecksville, Ohio, is seeking a Regulatory Affairs Specialist to prepare submissions to FDA and international bodies and to ensure... ..., support procedure development, and coordinate with global teams to manage registrations and changes. Strong attention...Suggested
$120k - $180k
...Aug 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain... ...for the person to work EST hours. The Medtronic Global Regulatory Affairs team is looking for a highly motivated and skilled individual...SuggestedFull timeH1bWork at officeLocal areaImmediate startFlexible hoursShift work$128.11k - $180.87k
R&D Partners is actively seeking a Regulatory Affairs Specialist III to join their team in Fort Worth, TX. In this role, the specialist will provide submission management support for Global Regulatory Affairs and ensure compliance with regulatory requirements. The position...Suggested- Laborie Medical Technologies is seeking a Regulatory Affairs Specialist for a hybrid role in Minnetonka, MN. You will support global product registrations and lifecycle maintenance for the US, Canada, Europe, and other regions. Responsibilities include preparing submissions...Suggested
- Applied Medical is seeking an Associate Specialist in Premarket Regulatory Affairs to join our on-site team in California. You will support regulatory strategy, global submissions, and QMS compliance while collaborating with cross-functional teams to ensure products meet...Suggested
- Safeguard Medical is seeking a Regulatory Affairs Specialist based in Huntersville, North Carolina. This role involves managing regulatory submissions... ...strong communication skills, a solid understanding of global regulations, and proficiency in MS Office. Occasional travel...
- ...clinical-stage medical device company focused on transcatheter valve solutions for tricuspid regurgitation. We seek a Regulatory Affairs Specialist to support global regulatory activities across a growing portfolio and collaborate with Clinical, Quality, R&D, and Engineering...
- ...Ormco is seeking a Regulatory Affairs Specialist to drive global product registrations, maintain regulatory filings, and align with EU MDR requirements. You will collaborate with cross-functional teams and coordinate with global registration partners to support a broad...
- ...Medtronic, a global leader in healthcare technology, seeks a Regulatory Affairs Specialist within the Access and Instruments Operating Unit to support regulatory documentation, change control, and global compliance. You will partner with cross-functional teams to assess...
- ...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...
- ...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...
- ...Synergy Spine Solutions Inc. in Louisville, CO seeks a mid-level Regulatory Affairs Specialist to manage global regulatory lifecycle for the Synergy Disc and future spine devices. On-site in Louisville, CO with hybrid options, you will coordinate submissions, strategies...
- ...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...
- ...ICU Medical is seeking a Regulatory Affairs professional to support global and US registrations of medical device products. You will analyze regulatory requirements, create and maintain registration dossiers, and ensure compliance across submissions and change management...
- Urgomedical in Fort Worth, Texas, is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with global medical device regulations. This includes managing regulatory submissions and supporting product registrations. The ideal candidate will have a Bachelor...
- ...Hybrid role in Earth City, MO Job Title Senior Regulatory Affairs Specialist - Global Pet Care Job # US20011 Requisition Type Regular Function Legal & Risk State/Province Missouri City Earth City Region US Posting Start Date May-05-2026...Full timeWork from homeWorldwideMonday to Friday
- Sotera Health is seeking a Regulatory Affairs Specialist to support regulatory strategy, registrations, and listings for its Sterilization sites.... ...activities, FDA annual updates, and collaboration across global facilities to maintain regulatory readiness and effective...
- Theragenics, the parent company behind Arrotek, seeks a Regulatory Affairs Specialist to drive global regulatory compliance and submissions for medical devices across domestic and international markets. You will collaborate with Quality, Engineering, Operations, and Documentation...
- West Pharmaceutical Services in Exton, PA is seeking a Senior Specialist, Regulatory Affairs to lead regulatory strategy for medical devices and combination products, ensuring submissions meet US and global requirements and maintaining compliance across lifecycle. This...Relocation3 days per week
$100.32k - $125.4k
Sonova Group is seeking a Senior Specialist, International Regulatory Affairs in Santa Clarita, CA. This role focuses on supporting global regulatory activities for Class III medical devices, including obtaining and maintaining international approvals and compliance. Qualifications...- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. You will submit 510(k), PMA supplements, and global filings, while guiding regulatory strategy on new products and...
- Makro Scientific is seeking an experienced professional to join their Global Regulatory Affairs team. The role involves planning, writing, and compiling regulatory reports such as DSURs and NDA annual reports, as well as contributing to product regulatory strategy documents...
- AtriCure, Inc. is seeking a Regulatory Affairs professional to originate and maintain marketing privileges with global regulators, and to manage documentation for international distributors and customers. The role also supports pre-market submissions (IDE, PMA, 510(k))...
- Curium Pharma in the United States is seeking a Regulatory Affairs Product Specialist to support US FDA submissions (NDAs, ANDAs, DMFs) and international... ...staff, track regulatory changes, and maintain up-to-date knowledge of global guidelines. #J-18808-Ljbffr Curium Pharma
- ...engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China... ...world-class professional resources.Job DescriptionThis Global Regulatory Affairs (GRA) Labeling Associate position will ensure active...Local area
- Edwards Lifesciences is seeking an Associate Specialist in Regulatory Affairs Operations TMTT in California to contribute to global regulatory submissions and publications. You will coordinate deliverables, maintain regulatory records, and support audits, ensuring compliance...
- GLOBAL TRADE COMPLIANCE Why join Aptiv? You'll have the opportunity to work on cutting-... ...Procurement, Finance, Legal, Government Affairs, and Commercial teams throughout the region... ....• Support customs audits, regulatory inquiries, and trade-related litigation...Full timeTemporary work
$220k - $270k
...accomplished, talented, and highly motivated individual to serve as Global CDMO Compliance Officer for its FUJIFILM Biotechnologies... ...****@*****.***).Job SummaryRequisition ID: 2026-37198Category: Regulatory/ComplianceCompany (Portal Searching): FUJIFILM Holdings America...Contract workLocal areaFlexible hours$154.5k - $226.6k
...better for people around the world. We are a global healthcare leader headquartered in... ...point of contact serving Global Government Affairs and Import/Export/Trade Compliance... ...including but not limited to Medical, Legal, Regulatory, Privacy, Protect Lilly, Finance,...Full timeH1bWork at officeLocal areaVisa sponsorshipWork visaFlexible hours$91k - $165k
OverviewAt ST Engineering iDirect, we’re reshaping the future of global connectivity. As a leader in satellite communications, our... ...the beginning.ResponsibilitiesThe Senior Global Trade Compliance Specialist supports export compliance operations for SATCOM products, software...Full time
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