Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio.
Key ResponsibilitiesProvide strategic input on regulatory requirements for new technologies and product modificationsPrepare regulatory submissions, including 510(k) and CE mark documentationMaintain current regulatory knowledge and participate in internal and external auditsRequired Qualifications and EducationBachelor's degree with 2+ years of relevant experience or an advanced degree with no experienceExperience in medical device regulatory affairs is preferredKnowledge of FDA requirements and international regulationsExperience with Class II products (US) and Class I, IIa, and IIb products (EU)Regulatory Affairs Certification (RAC) is a plus
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices. ...
Principal Regulatory Affairs Specialist - Heart Failure (on-site)
As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU an...
Principal Regulatory Affairs Specialist
A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. FDA regulatory requirements and policyRegulatory experience within the medical device industry or a regulatory agencyExperience in advocacy related to healthcare policy and regulationsStrong research and analyt...
Principal Regulatory Affairs Specialist
As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU an...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio. ...
Regulatory Affairs Specialist
The Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Develops and supervises global Regulatory Affairs support function to leverage Subject Matter Expertise (SME) for completion of Customer requests, Regula...
Regulatory Affairs Specialist - II
Regulatory Affairs Specialist - II. The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our...
Regulatory Affairs Specialist II – Heart Failure (on-site)
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Prepares robust ...
Academic Program Manager II - (Hybrid)
Supervise the Academic Program Manager I positions within the School of Public Policy and serve as a liaison between the Academic Program Manager I positions and relevant faculty directors and administrators. Academic Program Manager II - (Hybrid). The Academic Program Manager II position in the Sch...
Technical Program Manager Contractor
A company is looking for a Technical Program Manager, Contractor in Marketing. ...