Toxicologist: Medical Products Specialist
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I am a Toxicologist with extensive experience working with regulatory submissions for medical products, pharmaceuticals and chemicals. I work with managing product portfolios in compliance to global regulatory requirements. I have specialist expertise in biological safety assessments, product design & verification, Sterilization and Clinical reporting.
My core values are to work with integrity, accuracy and efficiency. My goal is to help to drive business deliverables in cost effective and strategic ways which ensure patient and consumer safety while also shaping industry standards.
My specialist skill is scientific communication: I am adept at communicating scientific concepts, test needs/ costs and results to executive leadership teams, auditors, regulatory authorities and other high value stakeholders effectively to enable high value decision making.
I have worked in the life science industry since for over 5 years in numerous roles (Lab Engineer, Quality Control, Production, Regulatory affairs and Clinical departments). My professional career began fresh out of university where I worked for Sweden's national platform for nano-safety which gave me first hand experience working at regulatory legislation development for new technologies. My most recent position was a cross-functional role within a medical device manufacturing company where I was the subject matter expert for biological safety/biocompatibility, regulatory affairs and sterilization.
This role included managing a range of Class 1-3 medical devices and leading large projects to design and create their technical files for regulatory submission to global markets (EMEA, US, APAC). I have been directly involved in communicating with the FDA, Notified Bodies, working alongside CROs and providing consultancy for large global companies.
I also have niche experience working with: combination products, drugs, chemicals, intellectual property patents & antimicrobials/disinfectants.
Masters Degree Toxicology (Karolinska Institute, Stockholm, Sweden)
Bachelors Degree Biomedicine (University of Skövde, Sweden)
Both degrees provide extensive knowledge of human anatomy and physiology, molecular chemistry and microbiology. Toxicology degree provides specialist skills in chemical risk assessment, toxicity pathways and testing, alongside regulatory frameworks.
