Regulatory Affairs Specialist 1 - #765-2

**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 certifications considered but not required. **Education: Bachelor's Degree or country equivalent in Engineering or Science or related scientific discipline, or equivalent. **Training and Skills:Science knowledge must be able to digest complex data while keeping the big picture through good analytical skills. Excellent written and verbal communication skills with the ability to listen articulate and advocate. Proactive, high performance, results oriented and manager projects with ethical integrity. Technical system skills (MS Office applications, database efficient online research). Manage multiple projects and deadlines. Ability to identify compliance risks and escalate when necessary. Demonstrate both creative and critical thinking skills. Additional Requirement:Employee must pass criminal background verification Test Required:Yes Type of Test: Typing, Calculations/Math and Proofreading ** Applicants are required to complete an application and must possess the required basic qualifications to be considered for the position. Resumes are only accepted with a completed application ** Applications are available at the Helena Laboratories Human Resources Department located at 1530 Lindbergh Dr. Beaumont, TX or you may download an application from the Helena Laboratories website, www.helena.com, once completed scan and email to [email protected] or fax to (409) 842-3749. **Helena Laboratories Corporation is an equal employment opportunity employer, offering equal employment opportunities to all individuals and will not discriminate against any employee or applicant for employment because of religion, sex, sexual orientation, gender identity, race, color, national origin, age, protected veteran status, marital status or disability. EEO/AA ************************