Regulatory Affairs Specialist
Core
Provides customer support on regulatory issues, leads CE marking activities, develops 510K submissions, and supports global product registrations for medical devices.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Product registrations and regulatory submissions for medical devices
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Medical device regulations knowledge, Product registration, Risk management documentation, Change control strategy, Post-market surveillance, Internal/external audit support, Labeling and marketing claims review
Preferred skills
Science degree, Engineering change review, Global regulatory strategy
Technologies
MS Office (Word, Excel, PowerPoint)
Responsibilities
Lead CE marking activities per MDD and EU MDR, Develop 510K submissions and obtain FDA approval, Monitor and analyze evolving global regulatory requirements, Support engineering teams in creating risk management and FMEA documents, Review change requests and provide RA strategy, Support post-market surveillance activities, Participate in internal audits and support external regulatory inspections, Provide timely review and approval of product labeling and marketing claims
Seniority
Mid-level, hands-on IC