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
Senior Regulatory Affairs Specialist working independently, is responsible for fulfilling regulatory compliance requirements by applying an understanding of regulatory standards and regulations for medical devices, pharmaceuticals, or biologics. As a Senior Regulatory Affairs Specialist you play a p...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio. ...
Principal, Regulatory Affairs Specialist
We are actively seeking a highly skilled Principal Regulatory Affairs Specialist to lead our FDA, Health Canada, and/or EU MDR submissions process. Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and is responsible to communicate these changes...
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...
Director/Principal Specialist, Regulatory Affairs
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO. Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area. The Directo...
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices. ...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:. Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant with th...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:. Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT's laboratories are compliant with th...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:. Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT's laboratories are compliant with th...
Regulatory Affairs Specialist
Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant with the regulatory and accrediting organizations that oversee our laboratories. The Regulatory Affairs Specia...