What You’ll Bring to the Team
●Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent
combination of education and work-related experience.
●Working knowledge of medical device regulations, including ISO 13485 and EU IVDR (In Vitro Diagnostic Regulation); experience supporting regulatory documentation in an IVD or medical device environment strongly preferred.
●2 years of experience Regulatory Operations within a biotechnology, life sciences, or
chemical manufacturing company or another Regulated Industry.
●Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and
work instructions
●Familiarity with Quality Management Systems and electronic document control systems (eQMS)
●Experience with Google Suite and/or MS Office Products required.
●Experience with Master Control, Atlassian Confluence and/or JIRA preferred.
●Strong written and oral communication skills (timely, clear, concise, accurate, conclusive,
influential, targeted to audience) required.
●Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and
competing demands is required