Senior Regulatory Affairs Specialist, APAC
Core
Prepare regulatory submissions and maintain compliance for new or modified medical devices in domestic and international markets.
Role type
Senior Regulatory Affairs Specialist
Builds
Medical device clearances and approvals (FDA PMA/510(k), CE certifications)
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory submissions (510(k), PMA), CE file management, FDA/Notified Body interaction, SOP development, CAPA management, risk management, project management, knowledge of US/EU regulations
Preferred skills
Regulatory Affairs Certification, medical terminology, engineering concepts, manufacturing change control
Technologies
None stated
Responsibilities
Develop partnerships with cross-functional teams for product compliance, represent regulatory affairs on project teams, provide global regulatory strategies, communicate with US FDA and EU authorities, coordinate FDA PMA and 510(k) submissions, manage CE files and Essential Requirement checklists, respond to regulatory agency letters, review product labeling and promotional materials, support CAPA closure, participate in regulatory audits, write SOPs and train personnel
Seniority
Senior, hands-on IC