Principal Regulatory Affairs Specialist
A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy.Key ResponsibilitiesDevelop and execute U.
S. regulatory advocacy strategies and action plansMonitor and analyze U.S. regulatory guidelines, regulations, and policies related to medical devicesLead the preparation of document packages for regulatory submissions and recommend changes for complianceRequired QualificationsBachelor's degree plus 7+ years of related experience in the medical device industry or a regulatory agency (or 5+ years with an advanced degree)Demonstrable understanding of U.
S. 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 analytical skills with a global mindset
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
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Ability to interpret and apply regulatory requirements....
Senior Regulatory Affairs Specialist
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
Principal Regulatory Specialist
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. If you are passionate about regulatory affairs and eager to contribute to cutting-edge advancements, we would love to hear from...
Principal Regulatory Specialist
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. Regulatory Affairs, with experience in Class III medical devices. This ro...
Regulatory Affairs Specialist - Contractor
In this role, you will Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory ...
Regulatory Affairs Specialist
Title** : Regulatory Affairs Specialist with a Specialty in Labeling. Regulatory Affairs Certification is preferred but not required. Partners with other functions and Subject Matter Experts (SME's) to obtain information and/or data required for regulatory submissions. Anticipates regulatory obstacl...
Regulatory Affairs Specialist
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Regulatory Affairs Specialist (remote)
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
Senior Specialist, Regulatory Affairs, Critical Care
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...