Regulatory Affairs Project Manager F/M/X
Core
Lead regulatory and compliance design projects for drug delivery devices, ensuring normative compliance from requirements through post-marketing.
Role type
Senior Regulatory Affairs Project Manager
Builds
Drug delivery devices (inhalation, injection, nasal, dermal pumps, ophthalmic)
Domain
Medical devices / Pharmaceutical industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy definition, Quality Management System (QMS) development, GMP compliance, eCTD Module 3 CMC, CE certification, Notified Body Opinion process, Medical device design process, Gap analysis, Standardization committee participation
Preferred skills
ISO 11608, ISO 23908
Technologies
eCTD, ISO 13485, ISO 14971, MDR 2017/745, 21 CFR part 820
Responsibilities
Collaborate with development and production teams to implement regulatory activities; Prepare, verify, approve, and submit regulatory documents; Participate in drafting and verifying verification reports; Contribute to internal and external audits; Collect and interpret monitored standards; Summarize regulatory requirements; Support normative interactions with external stakeholders; Participate in standardization committees; Conduct impact analysis of product changes
Seniority
Senior, hands-on IC