Regulatory Affairs Specialist
Core
Planning and executing global regulatory activities to obtain and maintain regulatory approvals for medical devices, including preparing strategies for new devices, launch markets, and post-market changes.
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions and filings for medical device clearance/approval
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Knowledge of FDA regulations, ability to evaluate compliance with standards and laws, writing summary documentation, problem-solving
Preferred skills
Understanding of current regulatory environment
Technologies
None stated
Responsibilities
Determine requirements for product submissions and regulatory filings, communicate regulatory requirements to internal or external customers, review documentation and supporting evidence for compliance, complete and maintain regulatory filings by collaborating with internal and external groups, participate in development and substantiation of product labeling and claims, present project objectives and act as a regulatory resource
Seniority
Mid-level, individual contributor