A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices.Key ResponsibilitiesProvide regulatory strategic leadership for medical device products, including AI / ML-enabled devicesLead regulatory submission teams and guide cross-functional teams on regulatory decision-makingConduct regulatory training programs on relevant topics and review device labeling for complianceRequired QualificationsBachelor's degree in a technical or scientific field8+ years of experience in Regulatory Affairs submissions for medical devices and digital health productsExperience with FDA regulations and international standards for medical devicesTechnical proficiency in at least two relevant product categoriesAdvanced degree or regulatory certifications preferred
Senior Regulatory Compliance Specialist
A company is looking for a Senior Regulatory Compliance Specialist. ...
Senior Regulatory Affairs Manager (Open to Remote, Hybrid and Onsite Options)
The Senior Regulatory Affairs Manager will provide direct regulatory support for screening products. Director of Regulatory Affairs and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to market and keep them complaint. Support r...
Senior Regulatory Affairs Specialist
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. As a Senior Professional, a candidate will leverage candidate extensive expertise, integrating analysis, development, testing, and implementation within the candidate area of competence. Candid...
Senior Regulatory Affairs specialist
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applicatio...
Senior Regulatory Affairs Specialist - Vascular (on-site)
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Senior Regulatory Affairs Specialist. Assist in the development of regional regulatory strate...
Regulatory Affairs Specialist
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of ...
Senior Regulatory Affairs Manager (Open to Remote, Hybrid and Onsite Options)
Senior Regulatory Affairs Manager. Director of Regulatory Affairs and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to market and keep them complaint. Support regulatory activities throughout product lifecycle and maintain reg...
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
Regulatory Affairs Specialist II – Structural Heart (on-site)
Regulatory Affairs Specialist II. The individual will apply basic regulatory understanding to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Additionally will handle regulatory...
Regulatory Affairs Specialist
Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates, and regulatory inquiries. Minimum of 3 years regulatory affairs experience required with Bachelor's degree. Minimum of 2 years regulatory affairs experience with Advanced degre...