Regulatory Affairs Specialist III
Core
Ensure compliance with global regulations for product development, registration, and lifecycle management in the pharmaceutical, medical device, or diagnostics industry.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory strategies and submissions for diverse product portfolios
Domain
Life Sciences / Medical Devices / Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory requirements knowledge (FDA, EU MDR/IVDR), regulatory filing preparation (510(k), CE marking), quality systems expertise (ISO 13485, GMP/QSR), risk management, project management, analytical problem-solving, change control, post-market surveillance
Preferred skills
RAC certification, life sciences/chemistry/engineering/pharmacy background, regulatory staff development support
Technologies
Regulatory submissions software, Microsoft Office suite
Responsibilities
Develop and implement regulatory strategies, serve as liaison with regulatory authorities and stakeholders, prepare and submit regulatory filings, manage multiple projects simultaneously, support regulatory staff development
Seniority
Senior, hands-on IC
