Quality & Regulatory Affairs Consultant
Core
Support global consulting services by assisting with medical device registration, licensing, and compliance submissions across multiple regulatory markets.
Role type
Mid-level regulatory affairs consultant (medical devices)
Builds
Regulatory submissions and compliance documentation for medical device clients
Domain
Medical devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical device registration processes, regulatory gap analysis, client documentation review, regulatory reporting, procedure drafting, labeling review, audit response management
Preferred skills
Consulting experience, multi-market research project leadership, direct liaison with regulatory authorities
Technologies
Microsoft Office
Responsibilities
Prepare and submit medical device registration/licensing applications; assist with renewals and amendments; conduct gap analysis and review client documentation; draft and review quality assurance procedures and product labeling; respond to registrar/audit issues; research regulatory requirements and summarize findings; act as initial liaison with local regulatory authorities; support project teams with RA/QA priorities
Seniority
Mid-level, hands-on IC