Lead Specialist Regulatory Affairs
Core
Prepare high-quality regulatory documentation, support submissions, and ensure compliance for Maternal Infant Care products across the global product lifecycle.
Role type
Lead Specialist Regulatory Affairs (early career professional)
Builds
Global registration planning, submissions, notified body and quality system audits, and program implementation for medical devices.
Domain
Medical Technology / Regulatory Affairs
Required skills
Regulatory documentation preparation, global registration planning, submission support, compliance monitoring, technical document writing, regulatory research, risk identification, cross-functional collaboration, project management, time management.
Preferred skills
Experience in Quality Assurance, product design, engineering, manufacturing, clinical, or laboratory roles within regulated industries.
Technologies
None explicitly stated.
Responsibilities
Learn and apply country- and region-specific regulations and internal procedures; provide global RA support for registration planning, submissions, and audits; contribute to writing and editing technical documents for regulatory submissions; monitor changes to regulations and assess impact on products and commitments; develop working technical knowledge of assigned products; research relevant regulatory information and evaluate options; organize work and manage multiple priorities to deliver on timelines.
Seniority
Mid-level (6-8 years total experience, 3+ in regulated field), limited direct oversight.