Helena Laboratories Corporation
Beaumont, TX, USA
General Job Description Summary: Reports to and receives assignments, instructions and direction from the Director of Regulatory Affairs. Responsibilities include assistance in regulatory submissions, annual reports, registrations and listings, internal audits and government/supplier inspections. Employees will assure compliance with applicable medical device regulations per jurisdiction, guidance and standards and assist in creation and maintenance of regulatory files. Observes and follows all safety rules and procedures, including wearing required PPE. Performs various other duties and activities as directed by the Director. Must meet all elements of the Helena Standards Pertaining to All Jobs, Job Classification Standards – Job Requirements Matrix and General Job Requirements.
Experience: Experience in manufacturing operations or medical device industry, knowledge of ISO 13485-9001 Quality Management Systems Auditing and/or clinical experience. Relevant...