GET TO KNOW MEDFILES’ TEAM LEADERS

Heta Karvinen
Director, Pharma Regulatory Affairs

Heta Karvinen has worked at Medfiles since 2013. All in all, she has some 15 years of experience from pharmaceutical development, marketing application dossiers and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in the pharmaceutical industry.

She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the regulatory guidelines that govern such studies. Previously at Medfiles, Heta worked as a senior pharmaceutical chemical expert, utilising her skillset in various drug development projects as well as managing quality dossiers for human and veterinary medicines, post-approval variation applications and the studies required to support them. During the years, she has gained valuable expertise from active substance documentation in both the European Union and the United States. In February 2022, Heta was appointed Director of Pharma Regulatory Affairs at Medfiles.

Anna Alonen
Head of Operations, Pharma Regulatory Strategy

Anna Alonen joined Medfiles in 2014. As the leader of a team of marketing authorisation experts, Anna’s responsibilities encompass new marketing authorisation applications and regulatory strategies. Anna and her team are experienced in working with regulations.

Medfiles’ marketing authorisation experts have helped clients to plan regulatory strategies, successfully compiled marketing authorisation applications and coordinated application procedures.

Anna’s journey at Medfiles began as a marketing authorisation expert, a position in which she honed her skills and knowledge of the field. Armed with a Ph.D. in pharmaceutical chemistry, acquired during her tenure at the University of Helsinki, Anna brings with her a strong, academic educational background. Her past engagements at the Finnish Medicines Agency and Pharma Industry Finland have further enriched her expertise, equipping her with valuable insights into the broader pharmaceutical landscape. Anna’s wide-ranging skill set covers research, expert consultancy, team management and project leadership.

Ulla Orava
Head of Operations, CMC

Ulla Orava has worked at Medfiles since 2007. She has more than 20 years of experience from pharmaceutical development, product maintenance, marketing authorisation dossiers and post-approval variations. Before joining Medfiles, Ulla worked with assessment and coordination of variations at the Finnish Medicines Agency, as well as with drug product development and product maintenance in the pharmaceutical industry.

She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the guidelines steering these studies. In addition, Ulla has considerable competence in changes needed for drug products, problem solving, planning and classification of variations and writing variation documentation, not to forget a good grasp of how the authorities interpret variation guidelines. At Medfiles, Ulla’s roles as Head of CMC Operations, leading an extremely experienced team of CMC experts, and before that, as a CMC Expert, have allowed her to fully utilise her wide range of expertise in various drug development projects and in managing the quality dossiers for human and veterinary products and post-approval variation applications.

Mikko Reinman
Head of Operations, Pharma Regulatory Affairs

Mikko Reinman has worked at Medfiles since 2009. Biochemist and food chemist by education, Mikko has extensive laboratory experience, having worked as an R&D chemist and analytical chemist in several companies. During his career, Mikko has been involved in various pursuits, including developing analytical platforms and targeting technologies, as well as quality assurance and IPR issues.

After switching to pharma regulatory, Mikko has gained more than 15 years of experience in product maintenance, first at a pharma company and then at Medfiles. Mikko’s first position in the pharma regulatory field involved working with product information texts and local regulatory responsibilities, and later, he proceeded to global regulatory manager tasks, including marketing authorisation maintenance and variation strategies. At Medfiles, Mikko has also worked with pharmacovigilance, compliance, project management and marketing. Since 2014, Mikko has worked as a regulatory affairs manager, and today, his title is Head of Operations, leading a team of highly skilled regulatory experts.

Satu Kujala
Director, Pharmacovigilance

Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics. Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.

Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP).

Saara Mikkola
Head of Operations, Pharmacovigilance, EU QPPV

Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.

Saara has a master’s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.

She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.

Essi Sarkkinen
Director, Clinical Research and Medical Device

Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.

Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.

Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.

Eric Schwandt
Manager, Medical Device

For more than 20 years before joining Medfiles, Eric Schwandt has held a number of regulatory affairs, QMS management, and marketing positions in the medical device and IVD industry. Eric joined Medfiles in 2022 and is the manager of the Medical Device and IVD Regulatory Team. He has a M.Sc. in Oral Biology, focusing on the molecular biology of cancer.

This has led to particular experience and interest in autoimmune disease diagnostics, POC testing, immunohistochemistry, and radiation and laser product safety.

Jenni Liljavirta
Director, Food and Feed

Jenni Liljavirta is responsible for operations, internal development, and sales and business development, working closely with internal teams to ensure efficient and commercially relevant services. Jenni holds a PhD in veterinary immunology and a Master’s degree in biochemistry and brings over a decade of experience in the food, feed, and biosciences industry.

Jenni joined Medfiles in 2025 and has led the Food & Feed Unit since 2026. Before joining Medfiles, she worked in international companies leading global research projects on bioactive ingredients, including pro‑, pre‑ and postbiotics, immune health, and microbiota, gaining valuable people leadership experience while coordinating multidisciplinary and international research teams.

She has extensive experience in animal nutrition and feed, including the design and conduct of pre‑clinical and in vitro studies for animal dietary supplements and feed additives, supporting safety, efficacy, and regulatory requirements. Jenni has also built regulatory affairs expertise by producing scientific and technical materials for regulatory applications and by actively following developments in the regulatory field. Jenni has authored multiple peer‑reviewed scientific publications and is an inventor on patent applications and invention disclosures (IDNs). In addition to her professional skills Jenni is fluent in Italian and has good comprehension of French.

Mari Lyyra
Regulatory Affairs Manager, Food and Feed

Mari Lyyra holds an M.Sc. in Public Health, specialising in clinical nutrition, and is a licensed nutritionist. Early in her career, Mari began focusing on food regulatory tasks in the EU. With over 25 years of extensive experience, she is well-versed in regulatory and scientific work related to traditional foods, food supplements, functional foods with health claims, food additives, food enzymes, and innovative ingredients. 

Mari has worked for Medfiles since 2014 and led the Medfiles Food & Feed team in 2019-2025. Currently she is working as Regulatory Affairs Manager.

 Since 1999, Mari has concentrated particularly on novel foods, which has become her primary area of expertise. She has been involved in dozens of favourable novel food projects and dossiers in the EU. In addition to EU legislation and novel foods, she has also mastered US food legislation and practices, including GRAS and NDI for last 10 years. 

Over the past decade, she has also trained in animal feed regulations and contributed to numerous animal feed projects. Mari brings extensive experience in expert and strategic consulting for clients across various projects in both the EU and the United States. She has authored numerous articles for food journals and contributed to peer-reviewed scientific publications. In recent years, Mari has delivered several lectures on food regulation at various Nordic and international events.

Mari Eskola
Team leader, Regulatory Science and Reports //
Senior Regulatory Affairs Expert
Food and feed

Mari Eskola has over 25 years of international expertise in the chemical and regulatory safety of food and feed from the European Union and European national organisations as well as from the industry. Mari joined Medfiles in 2021. Since then, she has been involved in several projects on food and feed conducted for Medfiles’ clients.

Mari is a food chemist specialised in analytical chemistry and in 2002, she obtained a PhD degree in food science. She has worked for 10 years at the European Food Safety Authority (EFSA), carrying out EFSA regulatory risk assessments of contaminants in foods and feeds, where she also worked as acting and deputy head of the EFSA Contaminants Unit.

In addition, Mari has food and feed research and regulatory expertise from various other European institutes, such as the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the Austrian University of Natural Resources and Life Sciences and the former Finnish Food Safety Authority. Mari has international experience in managing projects and people, and she has authored several scientific publications comprising also many scientific EFSA opinions and risk assessments.

Pia Karjalainen
Team leader, Health claims and Nutrition //
Senior Regulatory Affairs Expert
Food and feed

Pia Karjalainen has advised companies on various topics within food regulatory and scientific affairs throughout the past 15 years. She has gained wide regulatory expertise for a vast range of food categories, such as food supplements, foods for special medical purposes, food additives, novel foods and conventional foods.

In recent years, Pia has expanded her areas of expertise to include animal feed and cosmetics.

Since the beginning of her regulatory career, Pia has focused on health claims, which has become her key competence area. She also has in-depth expertise in designing regulatory strategies for innovative ingredients. Her ability to understand the bigger regulatory picture and work with a solution-oriented attitude has led her to leading and handling many complex projects related to different product categories and borderline products.

Pia has earned a master’s degree in health sciences (nutrition) from the University of Eastern Finland. Prior to joining Medfiles in 2014, she worked with food regulatory affairs and as a registered dietitian in healthcare.

Maija Salmenhaara
Team Leader, Labelling //
Regulatory Affairs Expert
Food and feed

Maija has worked at Medfiles from 2019. Her expertise covers regulatory affairs in food and feed, and she has strong competence in regulations concerning food composition and safety, food labelling, nutrition and health claims, novel food ingredients, food supplements and fortified foods.

She is also very experienced with work related to animal feed composition, labelling and marketing claims, with a balanced set of skills in project management, client service and writing reports.

Maija has a M.Sc. degree in food sciences (nutrition) from 2007. Before Medfiles, Maija has worked both in governmental agencies and the private sector, focusing on nutrition research, risk assessment and market research.