Roskilde, Region Zealand, Denmark
MedTech/Pharma/Science/Innovation Breathe in the future - Breathe out the past! Remember how to honor and respect life with each breath, step, word, and thought. What you bless blesses you in return!
Ensuring business agility and compliance, creating a culture where change is anticipated and embraced. Extensive, specialized knowledge of product technical, design, operational and clinical development principles. Provides expert-level guidance on medical evidence generation and regulatory requirements. including the placing product on market, the post-market and product life cycle management. Planning and directing strategic scientific, clinical and medical activities, shaping the future of such strategies in a dynamic, innovative internal and external setting. Liaising with healthcare professionals, scientific communities, and institutions Develop and lead high-performing teams, fostering a culture of accountability, innovation, and continuous learning. Coordinate multifaceted projects that demand cross-functional cooperation, guaranteeing punctual completion and alignment with overarching objectives. Provide regulatory expertise, guidance and direction; Lead relationship building, conduct due diligence, and support negotiation of complex strategic alliance and agreements. Accountable to establish effective communication to ensure company objectives and milestones are met. Champion continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness. Lead in identifying risk, develop mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups. Anticipate, resolve, and communicate key compliance, technical, operational, and strategic issues that may impact development team or other business functions. Interfacing with appropriate internal and external resources to ensure on-time delivery for projects. Embrace proactive compliance strategies recognizing regulatory frameworks, digitization and multinational transactions all contribute to a landscape filled with complexity and position company as trustworthy partner in the eyes of our customers and regulators.
CTO/CPO, PRRC Bridging business strategy and technical aspects of product development, ensuring products meet user needs and relevant regulatory requirements; fostering a culture of innovation, collaboration, and continuous improvement to drive product excellence. Defining product strategy with overall business objectives; collaborating with stakeholders, understanding market trends, customer needs, regulatory and competitive landscape. Developing long-term product vision, overseeing the entire product development lifecycle, from ideation to execution and release. Expertise within scientific research, medical/clinical affairs, regulatory intelligence, compliance regulations and design control ensuring effective going to market strategies. Providing innovative, full-service solutions, components and devices within the MedTech and Pharmaceutical industries. User-centred design approaches/Human-centred design in healthcare Expertise within concept, design, development, medical devices, SAMD, DFM/DFA, manufacturing, metrology, mechatronics, materials, injection molding, silicone molding etc.
Planned career break. Intentional pause from years fulfilling career to take a self-designed sabbatical - volunteering activities - a wish to make a difference in the lives of young people & to contribute to the development of their social capital.
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), and EU 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.
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.
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.
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.
Educating nursing school students within areas such as Metabolism, Nutrition, Clinical Nutrition, Physiology, and immunology.