Regulatory Affairs Specialist

Deciphex

30d • Remote

About The Position

Deciphex is seeking a Regulatory Affairs Specialist to join their team, with a focus on supporting digital pathology products and services in the healthcare markets in North America. The ideal candidate will be responsible for ensuring that our digital pathology products and services comply with regulatory requirements. This is a remote role with some travel required to global offices. The specialist will be 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 including with AI technology in North America. They will maintain and implement compliance plans to ensure continued compliance for services and products in North America, and make submissions for regulatory and accreditation applications for new products/services to project timelines to the applicable regulatory bodies including state agencies such as US (FDA, CMS-CLIA-LDT), Canada (CAP, SCC). The role involves developing, compiling, and reviewing technical documentation for regulatory submissions in the USA and Canada, and supporting the Regulatory Affairs team with UK, EU, Rest of World (ROW) submissions as needed for digital pathology solutions and services. The specialist will lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities regarding regulatory submissions, license & accreditation applications, vigilance and compliance activities. They will also coordinate post market surveillance (PMS) activities, write and submit periodic regulatory reports, and establish, manage, and monitor the global regulatory requirements database. Keeping up-to-date on changing regulatory requirements and standards, conducting regulatory gap analyses, and developing internal and global policies & procedures are key aspects of this role. Additionally, the specialist will assist in maintaining the Regulatory Affairs Intranet site, collect and report on compliance metrics, support other members of the Quality team, review Change Requests, support employees with regulatory queries, customer audits, regulatory audits and inspections, perform internal & supplier audits, and develop and deliver company training modules on regulatory processes. International travel of approximately 10% will be required.

Requirements

• 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.

Nice To Haves

• Experience with digital pathology scanning equipment and software systems is a distinct advantage.
• Experience with laboratory billing practices, Stark Law, anti kickback, anti markupF rule would be a distinct advantage.
• Experience with AI technologies and emerging standards is an advantage.

Responsibilities

• Generate regulatory plans and strategies for digital pathology products and services including with AI technology in North America.
• Maintain and implement compliance plans to ensure continued compliance for 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 including state agencies such as US (FDA, CMS-CLIA-LDT), Canada (CAP, SCC).
• Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada.
• Support Regulatory Affairs team with UK, EU, Rest of World (ROW) submissions as needed for digital pathology solutions and services.
• Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities regarding regulatory submissions, license & accreditation applications, vigilance and compliance activities.
• Coordinate post market surveillance (PMS) activities for products and services.
• Write and submit periodic regulatory reports to authorities as required for regulatory purposes.
• 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): Change management, complaint handling, training, periodic document reviews, inputs for quality management reviews and guidance to peers and cross-functional groups etc.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees