Consultant Regulatory and Quality Affairs

6/2026 – offen

• Plan and author regulatory submissions and technical dossiers for medical devices, IVDs and software (SaMD/SiMD) in various countries.
• Work with local registration holders and Authorized Representatives to meet country-specific requirements and keep registrations and renewals on track.

Regulatory Affairs, Regulatory Affairs Manager

6/2022 – 1/2026

• Managed global registrations for Class A–C devices (EU, Canada, APAC, LATAM, MENA).
• IVDD→IVDR roadmap; CERs, PERs, PMSs, PSURs, SVAs, RMFs; incident/FSCA authority communications; PMS tracked via Salesforce
• Supported NB audits and health authority inspections; prepared technical documentation and compliance briefings for cross-functional teams.
• SaMD lead: IEC 62304/EN 82304 applied to connected diagnostic platforms (remote patient monitoring) and algorithm-driven signal-processing software — classification, documentation, and submission strategy.
• Managed incident reporting and FSCAs across multiple markets — coordinating with regulatory authorities and internal quality teams and tracking corrective actions through to closure.
• Act as PRRC (Art. 15) and main regulatory contact for Notified Bodies and Regulatory Authorities.
• Maintain post-market compliance: authored PMS procedures and 20+ PMS reports and 10+ PSURs, and reviewed vigilance reports (incidents/FSCA) before submission to authorities and Notified Bodies.
• Wrote and improved SOPs aligned with ISO 13485.

Quality Assurance Employee, Regulatory Affairs, Regulatory Affairs Manager

2/2022 – 6/2026

• Global registrations (FDA 510(k), NMPA China, MFDS, TFDA / APAC, Canada, LATAM, MENA) for Class I–III devices
• MDR-compliant STED files; MDD→MDR change assessments; Windchill PDMLink document control.
• Authored SOPs; supported vigilance, PMS, and adverse event reporting activities
• Supported internal and external audits, including preparation of audit-ready documentation
• Lead change-control and regulatory impact assessments for design and product changes across the product lifecycle, working with R&D and quality teams.

Regulatory Affairs, Regulatory Affairs Manager