Regulatory Affairs Specialist II

Bachelor’s degree in science discipline or related field with 2+ years of experience, or equivalent combination of education and/or demonstrated experience
Proven ability to use and apply technical standards, theories, concepts, and techniques
Strong oral, written, and interpersonal communication skills
High degree of accuracy and attention to detail
Proficient in Word, Excel, PowerPoint, and other computer tools
Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Assist in preparing moderately complex submissions to gain approvals such as: 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, IDE, International Clinical Trial Submission, Shonin, and Certificates to Foreign Government
Track multiple device projects concurrently [e.g., Design Control, post market activities, Device submission projects]
Ensure that regulatory documentation is maintained per internal procedures
Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed
Communicate and exchange accurate information with all stakeholders (i.e., project teams, health authorities, RA personnel, and management)
Support labeling reviews (e.g., Instructions for Use and product labels)
Understand the Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
Assist in various regulatory support activities (e.g. internal/external audits, Field Corrective Actions, FOIAs)
Perform other Regulatory department-related duties as assigned