Regulatory Affairs Specialist IVD Jobs in USA

OverviewResponsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance t...

Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear timely and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs an...

Job DescriptionOverviewWe are seeking a Senior Director - Licensing and Regulatory Affairs Energy to join our team in Oak Ridge TN.Your roleManages all international licensing activities performed by AtkinsRealis US Nuclear sub-contractors and affiliates on advanced nuclear and engineering projects...

Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of Do you want a workplace that will challenge you and offer you opportunities to learn and grow A position at Xcel Energy could be just what youre looking for.Position...

LocationOffice-based in Irving TXJob SummaryThe Regulatory Affairs Coordinator will act as liaison between NEXT Oncology the Institutional Review Board and various Pharmaceutical and Biotech companies (Sponsors) to open clinical trials at NEXT Oncology.Essential Duties and ResponsibilitiesEssential...

OverviewThe Manager Regulatory Affairs Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects owning regulatory deliverables and acting as a key point of contac...

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonra...

Responsible for technical support and product testing in the US with the objective to support sales and operations in growing the business. Primary focus on laboratory testing and regulatory compliance.Job FunctionsProvide technical support to sales teams and account managers internally and/or durin...

Full-timeDescriptionJOB PURPOSE: 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 genomic and proteomic biomarkers. Ensure alignment...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make...

Job Description:Sr. Scientific and Regulatory Affairs Manager - Packaging Sustainability As a member of Scientific & Regulatory Affairs (SRA) team the Sr. Scientific and Regulatory Affairs Manager - Packaging Sustainability leads Mars Snacking North America efforts to interpret apply and influence c...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 115000 collea...

Qualifications Bachelors Degree in Chemistry Biology Toxicology or related field. Experience in professional level position in business. Experience with OSHA/TSCA/RCRA/Export regulations desirable. Ability to manage multiple projects while effectively communicating status to senior staff. Excellent...

This role offers a rate of $22.00 per hour at this location. The compensation is fixed and does not vary based on qualifications.We are seeking a motivated Regulatory Affairs Intern to support core regulatory compliance activities including chemical data management and regulatory research while gain...

Regulatory Affairs SpecialistFridleyAbout HeraeusMaking displays foldable Helping hearts beat with medical innovations Or breathing new life into precious metals As a family-owned global technology group we help our customers to always being one step ahead.About Heraeus MedevioTogether we improve li...

Work Flexibility: Hybrid or OnsiteSenior Staff Regulatory Affairs SpecialistIrvine CaliforniaAs a Senior Staff Regulatory Affairs Specialist you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development quality and clinical teams. T...

This is whereyour work makes a difference.At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater...

About The RoleThe Staff Regulatory Affairs Engineer is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio. While many companies view Regulatory Affairs as a purely administrative function at Hinge Health we leverage this role as a technical di...

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...

About The RoleThe Staff Regulatory Affairs Engineer is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio. While many companies view Regulatory Affairs as a purely administrative function at Hinge Health we leverage this role as a technical di...