Staff Specialist, Regulatory Affairs
Core
Developing regulatory strategies and preparing submissions to achieve market access for Joint Replacement implant and instrument portfolio across U.S. and international markets.
Role type
Staff Regulatory Affairs Specialist
Builds
Regulatory strategies and market access submissions for medical device products
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, submission preparation, risk identification, compliance guidance, regulatory intelligence assessment, cross-functional training
Preferred skills
Master's in Regulatory Science, Regulatory Affairs Certification (RAC), knowledge of 510(k) and CE marking pathways, product lifecycle regulatory experience
Technologies
FDA submission systems, EU regulatory frameworks
Responsibilities
Assess regulatory intelligence and update global strategies, evaluate regulatory environment across product lifecycle, determine product classification and approval pathways, prepare and submit regulatory filings, identify regulatory risks and propose mitigations, provide guidance on quality and clinical documentation, communicate with regulatory authorities, develop regulatory procedures and train stakeholders
Seniority
Staff, strategic guidance & cross-functional leadership
