Senior Consultant in Medtech Compliance

Why This Job is For You At Knightec Group, we understand that improving patients' quality of life by ensuring medical technology products is of utmost importance. By balancing quality and regulatory compliance throughout the product development process, you play a crucial role in introducing new technology and more efficient medical equipment to the market. As a senior consultant with us, you are not just part of the team – you are a key player in our Center of Excellence Medtech Compliance. By driving training, workshops, and strategic initiatives, you shape our direction and deeply influence both customers and colleagues. We offer you a unique opportunity to grow professionally in an organization where your experience and ideas are valued. In our Compliance & Management business area, we support an effective transition to digital, sustainable, and secure solutions through expert knowledge in areas such as quality, safety, sustainability, and project management. Responsibilities The role is for you who recognize yourself in the following: • You want to improve patients' quality of life through safe and innovative medical technology solutions. • You have a vision for how quality and regulatory compliance can become a competitive advantage for our customers. • You are accustomed to taking leadership roles in complex projects, from start-ups to established international companies. • You are passionate about sharing your expertise and serving as a mentor for colleagues while contributing to customers' success. • You are not just an expert in Design Control, technical documentation, Quality Assurance, or regulatory requirements – you are a strategic partner helping our customers reach new heights. • You are driven to create long-term business relationships and see opportunities to challenge and develop both customers and our business. Qualifications You are an experienced compliance leader with the ability to think strategically and act operationally. You have an eye for detail but also understand the big picture. With strong technical knowledge and a deep understanding of the medical technology regulatory landscape, you are ready to step into a role where you lead and inspire. Additionally, we prefer that you have: • Engineering degree in biotechnology, medical technology, chemical engineering, or similar. • At least 7 years of experience working with product development quality in the medical technology industry, including areas such as Design Control, CE marking, Quality Assurance, Regulatory Affairs, or quality management systems. • Deep knowledge of relevant standards and regulatory requirements such as MDD/MDR, ISO 13485, ISO 14971, and IEC 62304. • Experience leading projects, building customer relationships, and contributing to business development. • Strong communication skills in Swedish and English, and an ability to navigate complex organizations. An Exciting Journey with Knightec Group Semcon and Knightec have merged as Knightec Group. Together, we form Northern Europe's leading strategic partner in product and digital service development – how amazing is that? With a unique combination of cross-functional expertise and a holistic understanding of business, we help our customers realize their strategies – from idea to finished solution. At Knightec Group, we have the competence, attitude, and drive required to take on the most challenging and innovative projects. For our employees, this means fantastic opportunities to help shape the future through meaningful projects at the absolute forefront of technology. Here, you not only develop and grow but also become part of something bigger. Does this sound like the place for you? Join us on an exciting journey! Practical Information This is a position at one of our offices in Gothenburg at Lindholmsallén 2 or Fabrikstorget 1, CityGate. Business travel to our customers may occur. Start date is as soon as possible or by agreement. Submit your application as soon as possible, but no later than 2025-12-07. If you have any questions about the position, please contact Talent Acquisition Partner, Lina Orfanidou. Please note that, due to GDPR, we only accept applications via our careers page. We look forward to hearing from you!