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Mary Igbudu

@maryigbudu

Quality Management and Regulatory Affairs Manager at Innoview GmbH, maintaining medical-device compliance across EU MDR and FDA submissions.

Germany

Message

At Innoview GmbH, I establish and maintain Quality Management System processes aligned with ISO 13485 and EU MDR 2017/745, supporting regulatory compliance and audit readiness.

I prepare and support regulatory submissions and product registration for EU MDR, FDA 510(k)/PMA, and international markets. I also conduct risk assessments and CAPA investigations, and manage process validation activities including IQ, OQ, and PQ.

As PRRC, I support product compliance under EU MDR Article 10(10) and manage post-market surveillance activities, including support for incident and vigilance reporting. I maintain technical and regulatory documentation to support inspections and audits.

Experience

Work history, roles, and key accomplishments

Current

PRRC (Person Responsible for Regulatory Compliance)

Current

Innoview GmbH

Oct 2023 - Present (3 years)

Support product compliance activities in accordance with ISO 13485 and EU MDR Article 10(10). Manage Post-Market Surveillance and support incident and vigilance reporting per MDR Articles 87–91.

ISO 13485 EU MDR Post Market Surveillance Vigilance Incident Reporting Regulatory Documentation Audit Readiness

Current

Quality Management / Regulatory Affairs Manager

Current

Innoview GmbH

Oct 2022 - Present (4 years)

Established and maintained QMS processes aligned with ISO 13485 and EU MDR 2017/745, supporting regulatory compliance and audit readiness. Prepared regulatory submissions and product registrations for EU, FDA, and international markets.

ISO 13485 MDR 2017 745 CAPA Risk Management Process Validation IQ+Technical Documentation SOPs DHF DHR Internal Audit Regulatory Submissions 510(K)PMA

Administrative & IT Support Officer

BrainOBrain Kids Academy

Mar 2017 - Mar 2019 (2 years)

Provided administrative and IT support for business operations and training activities. Managed documentation, performance monitoring, and capacity-building programs.

IT Support Documentation Performance Monitoring Data organization Troubleshooting User Accounts

Laboratory Scientist

Divine Health Laboratory

Jul 2015 - Dec 2016 (1 year 5 months)

Performed laboratory diagnostics and maintained compliance with testing standards. Conducted data entry, monitoring, and evaluation of laboratory results.

Laboratory Diagnostics Data Entry Monitoring Evaluation Record Maintenance Test and Validation

Laboratory / Research Assistant

Central Public Health Laboratory

May 2013 - Jun 2014 (1 year 1 month)

Conducted diagnostic testing including HIV, Rubella, Measles, TB, and Leprosy. Supported medical device performance testing and public health research.