Medical Device Regulatory Affairs and Quality Assurance Manager - (Dallas, TX)

We are a smaller medical device company with products marketed globally. Job Purpose Implement regulatory submission strategies and manage regulatory requests for a wide array of regulatory documents, statements and dossiers in coordination with Regulatory HQ. Provide consultation, guidance and recommendations to relevant Company Functions relative to matters of US Regulation and foster constructive interactions with Regulatory Agencies and Certification Bodies. Responsibilities • Implement regulatory compliance strategies in coordination with Regulatory HQ • Provide regulatory consultation to external industrial clients and internal customers to include Product Development, Manufacturing, Sales, Marketing and other Functions, on the local regulatory aspects of the business (e.g. applying laws, compliance to the internal procedures, documentary adjustment needs)