Experience

SPT VILECON

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Chief Technology Officer/Chief Product Officer (CTO/CPO)

  • Apr 2023 - Present

  Providing innovative, full-service solutions, components and devices within the MedTech and Pharmaceutical industries. User-centered design approaches/Human-centered design in healthcare Expertise within concept, design, development, construction of components/medical devices, DFM/DFA, manufacturing, metrology, mechatronics, plastics, injection molding, silicone molding etc. email: pks@sptvilecon.com Providing innovative, full-service solutions, components and devices within the MedTech and Pharmaceutical industries. User-centered design approaches/Human-centered design in healthcare Expertise within concept, design, development, construction of components/medical devices, DFM/DFA, manufacturing, metrology, mechatronics, plastics, injection molding, silicone molding etc. email: pks@sptvilecon.com



Convatec

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• Associate Director, Clinical Development, PMS & Regulatory Intelligence

  • 2019 - Oct 2022

  Head of Clinical Development, Infusion Care, ConvaTec (Diabetes, Parkinson Disease, Pain Management, Thalassemia, Primary immunodeficiency and mild/moderate rehydration). Responsible for Clinical Investigations, Clinical Evaluation/Clinical Evaluation Reports, and PMCF, Infusion Care, ConvaTec.Head of Regulatory Intelligence, R&D, Infusion Care, ConvaTec.Head of Post Market Surveillance, Infusion Care, ConvaTec.Head of Biological Evaluation & Drug Compatibility, Infusion Care, ConvaTec.Head of Usability/Human Factor, Infusion Care, ConvaTec.Person Responsible Regulatory Compliance, PRRC, EU MDR 2020 – October 2022:EU MDR 745/2017 Article 15(c): the post-market surveillance obligations are complied with in accordance with Article 10(10), andEU MDR 745/2017 Article 15(e): in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.Key participant monthly meetings with Notified Body.Key participant authority interaction e.g. FDA calls.Subject Matter Expert, Key participant internal/external audits.Leading Taskforces including but not limited to urgent submission/registration, authority request/feedback, B2B deliverables for clinical studies, investigational device exemptions etc. Show less

• Senior Clinical Research Specialist, Clinical Development & Regulatory Intelligence, Unomedical a/s

  • Feb 2018 - Apr 2019

  Head of Clinical Development, Infusion Care, ConvaTec (Diabetes, Parkinson Disease, Pain Management, Thalassemia, Primary immunodeficiency and mild/moderate rehydration). Responsible for Clinical Investigations, Clinical Evaluation/Clinical Evaluation Reports, and PMCF, Infusion Care, ConvaTec.Head of Regulatory Intelligence, R&D, Infusion Care, ConvaTec.

• Clinical Research Specialist, Unomedical a/s

  • Feb 2015 - Jan 2018

  Responsible for Clinical Investigations, Clinical Evaluation including Clinical Evaluation Reports, and Post-market activities, Infusion Care, ConvaTec.Responsible for literature reviews, search terms (MESH) and SOPs.Responsible for the conduction of Health Hazard Evaluations and SOPs.Knowledge of MDD 93/42, MDR 2017/745 FDA QSR’s GMP’s and ISO 13485, 14155, 14971, 62366 and 10993, Meddev 2.12-1 rev 8, 2.12/2 rev 2, 2,7.1 rev 3 and rev 4, 2.7/3, 2.7/4, NB-MED/2.12Rec1, blue book, IMDRF, ICH guidelines, MDSAP etc.To ensure compliance with internal clinical requirements as well as international standards and regulations. To initiate, design (including the making of protocols), perform and monitor clinical trials to maintain and create necessary clinical documentation (safety and performance). To provide clinical knowledge, support, training/education and advice to internal/external. To ensure at any time the necessary and updated clinical knowledge within relevant therapy areas. To drive the company Post Market Surveillance process, including collection of data, evaluation of data and creating reports. The overall responsibility of clinical trials (initiate, design, perform and monitor clinical trials. To evaluate and conclude on processed data from clinical trials) Estimating and starting-up and run necessary clinical trials covering field user tests, clinical trials, clinical statement evaluations ad hoc and to draw up and maintain Clinical Evaluations Reports in compliance with the clinical requirements in regulatory standards (including the making/writing of protocols) Clinical assessment/evaluation within the post-market process i.e. the continued review and approval of FMEAs: use and design. To ensure requirements regarding device clinical documentation is in compliance with regulatory requirements and standards. Providing input, review and approve product information including but not limited to Instruction for Use. Show less

• Regulatory Affairs Specialist

  • May 2014 - Jan 2015

  Responsible for submission packages and registration including re-registration of medical devices.Responsible for implementing and maintaining the effectiveness of the quality system.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Provide regulatory input to product lifecycle planning.Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.Subject matter expert; key participant internal/external audits. Show less



Danish Health Authority

• Government Administration
• 200 - 300 Employee

• Danish Health and Medicines Authority, Medical Devices, Scientific Officer

  • Mar 2013 - 2014

  Scientific officer employed by the Danish Medicines Agency administers the medical devices legislation in Denmark. Assisting in the drawing up of EU rules and guidance documents in the area in relevant European working groups. Scientific officer role within the Danish Medicines Agency is to conduct oversight of the notified bodies and to react if it becomes aware of safety problems involving specific types of medical devices. As part of this oversight, we respond to relevant medical device incident reports submitted to us by companies, healthcare professionals or citizens. Ensure effective and efficient responses to all medical device (including active implantable and in vitro diagnostic devices) vigilance and market surveillance issues that arise. Ensure that the assessment of technical data for medical devices (including active implantable and in vitro diagnostic devices) are carried out effectively and efficiently across the medical device regulatory activities. Ensure that accurate regulatory information is provided to and understood by economic operators and that medical devices assessed comply with relevant regulatory requirements. Ensure that specific projects are carried out as required. Provide support and technical advice within the Danish Agency Medical Devices Section as required. Show less



Bornholms Social og Sygeplejeskole

• External Lecturer, nursing school

  • Mar 2010 - Feb 2013

  Educating nursing school students within areas such as Metabolism, Nutrition, Clinical Nutrition, Physiology, and immunology. Educating nursing school students within areas such as Metabolism, Nutrition, Clinical Nutrition, Physiology, and immunology.



Parker instituttet, Frederiksberg Hospital

• Meta-analyst

  • 2006 - 2009

  Responsible for the preparation of study protocols. Key participant within the initiation, running and monitoring of clinical trials. Conducting systematic reviews. Conducting meta-analysis. Responsible for the preparation of study protocols. Key participant within the initiation, running and monitoring of clinical trials. Conducting systematic reviews. Conducting meta-analysis. Responsible for the preparation of study protocols. Key participant within the initiation, running and monitoring of clinical trials. Conducting systematic reviews. Conducting meta-analysis. Responsible for the preparation of study protocols. Key participant within the initiation, running and monitoring of clinical trials. Conducting systematic reviews. Conducting meta-analysis.