Based on unique science and technology, Airlich delivers sustainable and environmentally-friendly HVAC solutions that improve indoor air quality, reduce energy costs, and lower a building’s overall carbon footprint. All while providing the health and productivity benefits of clean air - with a clean conscience.

• Heading Release & Actives (21 FTE’s, 14 direct reports including one Team Manager) with the ambition of transforming Coloplast devices into bioactive devices to make a clinical difference for users.• Build and maintain a strong professional team and a culture where there is a balance between academic ambitions and delivery deadlines. • Driving and developing the R&D Analytical team to ensure that the required competences and analyzes are available for the product development projects and to meet increasing regulatory requirements. • Financially responsible for Department and Technology projects in own area• Setting direction and ambition of Technology in Coloplast though active involvement in Management group responsible for >175 FTEs.

Key Responsibilities • R&D activities spanning from early concept development to late stage development leading to regulatory approval for Class III medical devices (implants).• Leading cross-functional projects with strict timelines with multiply partners from both industry and academia in leading national- and international universities and hospitals. • Design, conduct and reporting of experiments to support regulatory approval. • Interactions with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) ensuring company process fulfilled within defined protocols and in compliance with regulatory requirements. • Attraction of soft funding from external sources to support continues company innovation and development.Experience With• Regulatory interactions with European Notified Bodies (CE) and US FDA (510k and De Novo) for medical device approvals• Quality Management (ISO 13485) including audits and inspections. • Design Control (ISO 13485 and 21 CFR Part 820) and Risk Management (ISO 14971) of medical devices