Jenny Fäldt, PhD

Clinical Evidence & Regulatory Strategy Experience

Evidence strategy & Planning

Developed new approaches for pre-clinical evidence generation in early research projects.
Since 2018, led clinical evidence strategies integrating regulatory requirements, market access, and clinical acceptance.
Provided key input for evidence strategies supporting the transition of products from MDD to MDR.

Clinical Evidence Evaluations

Delivered Clinical Evaluation Plans (CEP) and Reports (CER) for medical device products.
Played a critical role in ensuring compliant and timely evaluations during the MDD to MDR transition.

Clinical Evidence Generation

Designed and executed clinical studies ranging from registry studies to multicentre RCTs, primarily in wound care (e.g. dressings, topical applications, and negative pressure therapies).
Oversaw statistical planning and data management throughout the study lifecycle.
Ensured clinical compliance across all study phases.

Regulatory Compliance & QMS establishment

Led regulatory applications for CE marking and established Quality Management Systems (QMS) for medical devices.
Completed accredited ISO 13485:2016 Auditor Training (2025), with focus on interpreting and applying QMS requirements.
Gained expertise in audit planning, execution, and reporting, including conformity assessments aligned with MDR (EU) 2017/745.
Demonstrated proficiency in supplier evaluations, internal audits, and regulatory compliance verification in line with Notified Body practices.

Research Strategy & Innovation

Initiated and led new research areas by establishing collaborations with universities and institutions, resulting in novel knowledge, innovations, and treatment concepts in dental care.
Developed and executed research platforms focused on absorption and skin health across medical devices and fast-moving consumer goods.
Defined strategies for pre-clinical evidence generation and created effective delivery frameworks to support them.

Evidence Governance

Designed and implemented a governance structure for evidence strategy and generation within the Medical Device sector.
Ensured efficient and purpose-fit clinical evidence generation through structured processes and strategic oversight.

Leadership & Team Development

Built and led the global clinical affairs leadership team.
Identified key competencies across functional areas and recruited talent to foster high-performing, collaborative teams.

Selected Work Experience

Senior Advisor and Consultant

JeFa Group AB + Structura MedTech Partner AB

2024 – Now

Focus on supporting companies in developing and implementing business strategies focused on evidence generation. Guiding and creating clinical evidence strategies for products and solutions, tailoring their purpose and priorities, addressing any identified gaps.

Acting CEO for small startup CerInvent AB. Founded Structura with Stefan Book, December 2025.

Global Director Clinical Affairs

Mölnlycke Health Care AB

2018 – 2024

Built up and leading the Clinical Affairs team, including Clinical Operation (conduct clinical trials), Clinical Evidence Evaluation, Clinical Evidence Strategy, Clinical Data Science & Statistics, and the Clinical Compliance & Safety.

Set governance structure to secure a more efficient and effective way of working and provided return of investment done in clinical evidence generation, for all business areas (i.e. wound care, gloves, antiseptic and surgical). Established an efficient clinical affairs leadership team to align and harmonize across the collaboration.

Global Research Director Absorption & Skin Health

Essity (former SCA Hygiene Products AB)

2014 – 2018

Leading the global research team within Absorption and skin health. Developed and delivered on research platforms, providing innovations for all business areas within the global hygiene category that lead to a competitive advantage for the business.

Through change management established a new way of working with close collaboration and interaction all the way from early research to each business category.

Director Biological & Clinical Systems

Nobel Biocare AB

2005 – 2013

Created the foundation for identification and delivery of new innovations.

Successfully set up an in-house biological laboratory where future treatment concepts for soft- & hard tissue were delivered. Shaped the way of collaborating with scientific advisors in projects to obtain credibility for new innovations and treatments concepts.

Post doc

Göteborg University, RCEM

2002 – 2005

Established a new research project, combining obesities research with immunology.

Developed new techniques for basic research and understanding, as well as transferred ideas to understanding impact of heavy exercise on immune system.