Open to opportunities

Anna Moehlmann

@annamoehlmann

Regulatory Affairs Specialist and Quality professional driving compliance and continuous improvement for medical devices.

Switzerland

Message

What I'm looking for

I am looking for a role in medical device regulatory/quality where I can lead compliance, improve systems with Lean/Six Sigma, manage market registrations, and work within an international team.

I am a Regulatory Affairs Specialist and experienced Quality Manager with a strong passion for compliance, systems and standards in the medical device industry. I combine hands-on regulatory registrations, post-market surveillance and biocompatibility expertise with robust quality management leadership across international markets.

Throughout my career I have led ISO 13485/MDR implementation, supplier and internal audits, CAPA and risk management, and product relaunch projects, while driving continuous improvement using Lean and Six Sigma methods. I have managed registrations and technical documentation for multiple markets including Switzerland, EU, UK, China and India.

I work effectively in international teams, speak German and Russian natively, English fluently and basic French, and I seek roles where I can improve systems, ensure regulatory compliance and support market access for safe, high-quality medical devices.

Experience

Work history, roles, and key accomplishments

Current

Quality and Regulatory Executive

Current

Marflow AG

Nov 2024 - Present (11 months)

Lead regulatory and quality activities for medical devices, ensuring compliance with international regulations and overseeing technical documentation and registrations across multiple markets.

Regulatory Affairs ISO 13485 MDR Technical Documentation Biocompatibility Risk Management

Regulatory Affairs Specialist

Medmix Switzerland AG

Dec 2022 - May 2024 (1 year 5 months)

Managed regulatory compliance and product registrations for medical devices and maintained technical documentation and material statements for global market access.

Regulatory Affairs Technical Documentation Product Registrations REACH RoHS Biocompatibility

Quality/RA Manager

Swiss Dental Solutions

Jan 2022 - Nov 2022 (10 months)

Managed quality and regulatory responsibilities for a legal manufacturer of medical devices, implemented PMS processes and led auditing of six outsourced production facilities.

ISO 13485 MDR Quality Management PMS CAPA Product Relaunch Project Management

Customer Auditor

Lonza

Jul 2021 - Sep 2021 (2 months)

Planned and executed customer audits in the pharmaceutical industry, tracking deviations and analyzing audit processes to support continuous improvement.

Customer Audits

Quality Engineer

HARTMANN SA

Oct 2018 - Jun 2021 (2 years 8 months)

Led production risk management and internal/supplier audits while implementing ISO 13485/MDR requirements and driving Lean/Six Sigma continuous improvement projects.

Risk Management ISO 13485 MDR Lean Six Sigma Continuous Improvement Supplier Management

Quality Manager

HARTMANN AG

Mar 2017 - Sep 2018 (1 year 6 months)

Responsible for plant quality management, supplier audits, CAPA coordination and implementation of corporate ISO 13485/MDR processes with direct reporting to plant management.

Quality Management CAPA Change Control ISO 13485 MDR SAP Lean

Marketing/Sales Manager

KNM Group

Jun 2010 - Feb 2017 (6 years 8 months)

Planned and executed international marketing campaigns, market analysis and customer engagement activities including trade show coordination and audit participation.

Marketing Strategy Market Analysis Campaign Planning Trade Shows Customer Audits

Education

Degrees, certifications, and relevant coursework

Westsächsische Hochschule Zwickau

Diplom Kauffrau, Business Management

2005 - 2010

Activities and societies: Diploma thesis at Heraeus Group; internship at Daimler AG; abroad internship in combined social and business projects in Sri Lanka.

Completed a Diplom Kauffrau in Business Management with a diploma thesis at Heraeus Group and internships including Daimler AG and international project experience in Sri Lanka.