Regulatory Affairs Specialist 1

Helena Laboratories Corporation   Beaumont, TX   Full-time     Manufacturing / Production / Operations
Posted on January 18, 2023

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. Employee 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. 

Experience: Experience in manufacturing operations or medical device industry, knowledge of ISO 13485 or 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: ŸScientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills. ŸExcellent written and verbal communication skills with the ability to listen, articulate and advocate. ŸProactive, high performance, result oriented and manage projects with ethical integrity. ŸTechnical system skills (e.g. MS office applications, databases, efficient online research). ŸManage multiple projects and deadlines. ŸAbility to identify compliance risks and escalate when necessary.  ŸDemonstrate both creative and critical thinking skills.

Additional Requirements:  Employee must pass criminal background verification.

Test Required:  Yes                Type of Test:  Typing, Calculations/Math, Proofreading

Helena is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age protected veteran status or disability.


Helena Laboratories Corporation

1530 Lindbergh Drive
Beaumont , TX