Regulatory Affairs Specialist

🕒 vor 1 Monat

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Deciphex

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51 - 200 Mitarbeiter

🤖 Künstliche Intelligenz

⚕️ Krankenversicherung

🧬 Biotechnologie

Artificial Intelligence • Healthcare Insurance • Biotechnology

Deciphex ist ein führendes Unternehmen, das das Gebiet der Pathologie revolutioniert, indem es Pathologen weltweit digital vernetzt und künstliche Intelligenz einsetzt, um die Effizienz und Qualität der Pathologieberichte zu verbessern. Pathologie ist sowohl für die Gesundheitsversorgung als auch für die Arzneimittelentwicklung von entscheidender Bedeutung, und Deciphex adressiert die wachsende Nachfrage-Liefer-Lücke in diesem Bereich durch den Einsatz digitaler Pathologie zur Arbeitslastverteilung und KI zur Beschleunigung von Prozessen. Das Unternehmen spezialisiert sich auf die Bereitstellung digitaler Pathologieplattformen wie Diagnexia und Patholytix, die sowohl die klinische als auch die Forschungs-Pathologie unterstützen. Deciphex ermöglicht bedarfsgesteuerte Remote-Konsultationen mit Fachpathologen, beschleunigt diagnostische Durchlaufzeiten und verbessert die Patientenversorgung. Ihre Plattformen werden von führenden CROs und Pharmaunternehmen vertraut, wodurch Deciphex eine zentrale Rolle im Bereich der digitalen Pathologie und KI-gesteuerten Lösungen einnimmt.

Beschreibung

• This is a remote role with some travel required to global offices. • Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services. • Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America. • Make submissions for regulatory and accreditation applications for new products/services to project timelines to the applicable regulatory bodies. • Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada. • Support Regulatory Affairs team with UK, EU, Rest of World submissions as needed. • Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities. • Coordinate post market surveillance (PMS) activities for products and services. • Write and submit periodic regulatory reports to authorities as required. • Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with global regulations. • Keep up to date on changing regulatory requirements and standards including FDA/LDT rule changes, emerging AI regulations, privacy/security regulations etc. • Conduct regulatory gap analyses and impact analysis. • Develop internal and global policies & procedures to ensure continuous compliance with all regulatory requirements. • Assist in maintaining the Regulatory Affairs Intranet site. • Collect and report on compliance metrics as directed by the Regulatory Affairs Manager. • Support other members of the Quality team to incorporate regulatory requirements into the Integrated Management System (IMS). • Review of Change Requests for product & service changes which may impact regulatory and customer filings. • Support employees with regulatory queries, customer audits, regulatory audits and inspections as required. • Perform internal & supplier audits as required. • Develop and deliver company training modules on regulatory processes. • Complete all mandatory company training and job specific training required for the role, including Information Security Management System (ISMS), GLP, DocuSign, SDLC as applicable.

🎯 Anforderungen

• Bachelor's degree in Computer Science or Life Science industry. • 3+ years experience in regulatory affairs in a regulated life science industry in USA. • Experience with histopathology laboratory accreditation to such standards as CAP, CLIA (USA), ISO 15189:2022. • Experience with SaMD and medical device regulations is required. • Experience with digital pathology scanning equipment and software systems is a distinct advantage. • Experience with laboratory billing practices, Stark Law, anti kickback, anti markup rule would be a distinct advantage. • Experience with AI technologies and emerging standards is an advantage.

🏖️ Vorteile

• A true sense of meaning in your work by contributing to better patient outcomes. • The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment. • A chance to work on exciting and challenging unique projects. • Regular performance feedback and significant career growth opportunities. • Competitive salary with performance based annual increments. • A highly collaborative and supportive multi cultural team.