Open to opportunities

Jenny Tolksdorf

@jennytolksdorf

Message

I build EU importer and global QMS processes for IVDR, MDR, CAPA, and post-market compliance.

Germany

Message

What I'm looking for

I'm looking to contribute my IVDR/MDR, EU Importer, CAPA, and global QMS experience in a collaborative environment focused on regulatory excellence, practical process improvement, and cross-functional alignment.

At Leica Biosystems, I help implement EU Importer obligations under IVDR across global manufacturing sites, covering product classification, documentation verification, conformity assessment, labelling, declarations of conformity, and EUDAMED registration.

I've served as Global CAPA Subject Matter Expert during the IQVIA SmartSolve eQMS integration, harmonizing CAPA workflows and supporting alignment with IVDR, ISO 13485, and MDSAP. I also strengthen PMS, recall, vigilance, audit-readiness, and environmental compliance processes across Quality, Regulatory, Trade Compliance, and manufacturer teams.

Previously, I managed compliance applications, supplier processes, contracts, and training at Alcon, and bring experience in legal compliance administration, documentation, and process standardization. I value precision, integrity, bilingual English/German communication, and practical continuous improvement.

Experience

Work history, roles, and key accomplishments

Current

Senior Specialist, Regulatory Compliance

Current

Leica Biosystems

Jan 2021 - Present (5 years 7 months)

Implemented EU Importer obligations under IVDR across global manufacturing sites. Served as Global CAPA SME during IQVIA eQMS integration, harmonizing processes and ensuring compliance.

IVDR MDR CAPA ISO 13485 MDSAP REACH RoHS WEEE SOP Development Audit Preparation Post Market Surveillance Risk Assessment Document Control SAP

Regulatory Compliance Specialist

Alcon

Jan 2018 - Dec 2020 (2 years 11 months)

Managed compliance applications and supplier management for HCP engagements across EMEA. Optimized compliance workflows using Alcon Compliance Tool and supported audit readiness.

Compliance Supplier Management SAP Alcon Compliance Tool Audit Readiness Training Process Standardization Data Integrity

Sales & Compliance Associate

Vorwerk

Jan 2014 - Dec 2018 (4 years 11 months)

Managed client acquisition, trade fair events, and sales reporting. Coordinated promotional compliance and product documentation for distribution.

Client Acquisition Sales Reporting Compliance Product documentation

Legal Compliance Assistant

Maucher Börjes Jenkins Patent & Law Firm

Jan 2014 - Dec 2015 (1 year 11 months)

Coordinated legal documentation, audits, and regulatory correspondence with patent authorities and clients. Assisted in developing internal compliance and quality procedures.

Legal Documentation Audit Compliance Training Materials