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
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A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio. ...
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