Regulatory Affairs Senior Specialist - Supply Chain Projects
Core
Primary regulatory point of contact for Supply Chain projects, assessing regulatory risks and driving compliance for operational changes in manufacturing and distribution.
Role type
Senior Regulatory Affairs Specialist (Supply Chain)
Builds
Regulatory compliance and documentation for global medical device supply chain transformations and manufacturing changes.
Domain
Medical Devices / Regulatory Affairs / Supply Chain
Deliverable
client delivery
Required skills
Global medical device regulations (21 CFR820, EU MDR, ISO 13485), regulatory operations, document control systems, risk assessment, cross-functional project management, stakeholder alignment
Preferred skills
Supply chain experience, global registration support, manufacturing transfer expertise
Technologies
EUDAMED, FDA FURLS, document control systems
Responsibilities
Lead regulatory assessment and documentation for manufacturing changes and distribution requirements; Collaborate with cross-functional teams to resolve regulatory queries; Identify and escalate regulatory risks linked to operational changes; Monitor international regulations and communicate updates; Support audits, inspections, and regulatory submissions; Maintain regular updates with RA teams regarding SC changes.
Seniority
Senior, hands-on IC