Regulatory Affairs Principal, IVD NPD - Kelly Services : Job Details

#x 9; Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches. Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required. Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU. Implements continuous improvements and efficiencies using DBS tools. Qualifications Bachelors degree in field with 8 years of related work experience OR Master's degree in field with 6 years of related work experience OR Doctoral degree in field with 3 years of related work experience Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and submissions (510(k), De Novo, Class A, B & C). Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions that are in scope for th...Regulatory Affairs, Regulatory, Principal, Clinical Research, Business Services, Staffing