Regulatory Affairs Specialist

🕒 Abril 17

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Deciphex

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🤖 Inteligência Artificial

⚕️ Seguro de Saúde

🧬 Biotecnologia

Artificial Intelligence • Healthcare Insurance • Biotechnology

A Deciphex é uma empresa líder que está revolucionando o campo da patologia ao conectar patologistas globalmente por meio de redes digitais e aproveitando a inteligência artificial para melhorar a eficiência e a qualidade dos relatórios de patologia. A patologia é crucial tanto para a entrega de cuidados de saúde quanto para o desenvolvimento de medicamentos, e a Deciphex atende à crescente lacuna entre demanda e oferta neste campo ao usar a patologia digital para balancear a carga de trabalho e a IA para acelerar os processos. A empresa se especializa em fornecer plataformas de patologia digital, como Diagnexia e Patholytix, que suportam a patologia clínica e de pesquisa. A Deciphex possibilita consultas remotas sob demanda com patologistas especializados, acelerando os tempos de resposta diagnóstica e melhorando o atendimento ao paciente. Suas plataformas são confiáveis por importantes CROs e empresas farmacêuticas, fazendo da Deciphex uma entidade central em soluções de patologia digital e IA.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.