Senior Regulatory Affairs Specialist
Core
Lead regulatory affairs activities for medical device projects, managing global submissions, regulatory strategies, and compliance with health authorities.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Premarket documents, regulatory files, and submission packages for global registrations.
Domain
Medical Devices / Healthcare Technology
Required skills
Regulatory strategy development, global registration preparation, regulatory file management, compliance monitoring, stakeholder collaboration, process improvement, agency communication, document consolidation, procedure authoring, peer coaching.
Preferred skills
None explicitly stated as preferred capabilities (listed as 'Nice to have' soft skills are excluded).
Technologies
None explicitly stated.
Responsibilities
Lead development and maintenance of regulatory files and reporting systems; prepare and review premarket documents for global registrations; compile materials for submissions and license renewals; recommend changes for labeling and manufacturing compliance; monitor regulatory environment changes; document communications with health authorities; coach peers on international submissions.
Seniority
Senior, independent contributor with general supervision.