Roberto Cunha

Head of Regulatory Affairs and Compliance @Bloomlife Inc

Miami-Fort Lauderdale, FL, US
EMAILS
r••••••@bloom-life.com
MOBILE NUMBERS
+14•••••••51

Signup · Get unlimited contacts

WORK HISTORY

Nov 2020 — Present

Head of Regulatory Affairs and Compliance @Bloomlife Inc

View department →

San Francisco, CA, US

EDUCATION

1990 — 1995

Universidade Federal de Pernambuco

Bachelor of Science (B.S.), Chemical Engineering

1990 — 1995

UFPE

BSc, Chemical Engineering

SKILLS

Corrective and Preventive Action (Capa)Commercialization510 KRegulatory AffairsContinuous Improvement21 CfrIsoPharmaceutical IndustryFdaR&DRoot Cause AnalysisQuality ControlBiomedical EngineeringGmpProduct DevelopmentTechnology TransferIso 13485Iec 60601Regulatory RequirementsChange ControlQuality AssurancePmaQuality AuditingComputer System ValidationClinical TrialsDesign ControlManufacturingDiagnosticsQuality SystemV&VProcess SimulationLean ManufacturingValidationCross-Functional Team LeadershipBiotechnologyIso 14971Ce MarkingResearch and Development (R&D)CqaQuality Management

ABOUT ROBERTO CUNHA

Accomplished multilingual engineer with 23+ years global medical device experience. Knowledge in the areas of regulatory affairs, regulatory compliance, quality assurance and risk management from initial phases of product development to commercialization/post-market activities. Successful US – PMA, 510(k), European, Canadian and global device regulatory approvals. Recognized leader with strong planning, strategic, negotiation and interpersonal skills.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Roberto Cunha — Email, Phone Number & Contact Info | Unifers