Deciphex

Regulatory Affairs Specialist

Deciphex

full-time

Posted on:

Location Type: Remote

Location: United States

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Tech Stack

SDLC

About the role

  • 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.

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.
  • 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.
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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairstechnical documentationregulatory submissionscompliance plansregulatory gap analysisimpact analysisinternal auditssupplier auditstraining module developmentlaboratory accreditation
Soft Skills
communicationengagementcoordinationorganizational skillsleadershipproblem-solvingcollaborationreportingsupporttraining
Certifications
Bachelor's degree in Computer ScienceBachelor's degree in Life ScienceCAP accreditationCLIA accreditationISO 15189:2022 certification