Regulatory Compliance Manager

QRIOS AB

Inossia is now recruiting a Quality Assurance (QA) Manager to the company. The position is full-time and based in our headquartered office in Stockholm and we are looking for a new colleague to join the team at Inossia. Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia® provides vertebral augmentation solutions that have been adapted to the mechanical properties of bone that will give Better fracture treatment for Osteporotic Bone. The company is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care As a QA Manager, you will be responsible for managing our QMS and overseeing product releases. You will lead training on new SOPs and collaborate closely with our Production Manager to ensure accurate and compliant documentation. Additionally, your responsibilities will include preparing the organization for audits and conducting supplier audits. At Inossia, you will get the unique opportunity to build, shape and optimize our processes from the inside out, make a positive impact and apply your experience and expertise within QA to ensure the highest quality standards. If this sounds interesting to you - Come join us and be part of our mission of improving fracture treatment for osteoporotic patients so that they can live an active life. We will interview candidates continuously and welcome your application today! Responsibilities The QA Manager will have a central role in oversight and management of manufacturing and analytical activities from a quality perspective. You will report directly to the Director of QA/RA at Inossia. Your main responsibilities will include: Lead, maintain, and continuously improve the Quality Management System in accordance with ISO 13485 and applicable medical device regulations Ensure compliance throughout the medical device product lifecycle, from development and design through manufacturing, release, and post-market activities Oversee risk management activities, including risk files, benefit-risk analysis, and lifecycle updates Plan, conduct, and support internal and external audits, including notified body, supplier, and regulatory audits Act as a key point of contact for audit readiness, responses, and corrective actions Manage CAPA, non-conformances, deviations, and change control processes Collaborate cross-functionally to ensure quality is embedded across the organisation Support supplier quality management, qualification, and ongoing performance monitoring Ensure robust documentation control, version management, and data integrity Contribute to key strategic developments within the QA department. Your Profile Key Qualifications for the position include: Multiple years of QA experience within the medical device industry, preferably in a smaller-sized company Strong hands-on knowledge of ISO 13485 and ISO 14971 Proven experience leading and supporting audits and inspections Solid understanding of medical device quality systems, risk management, and product development processes Experience working in cross-functional, international environments Fluency in English, both in speaking and in writing We are looking for someone with a can-do attitude, strong organizational skills and a quality-driven mindset. You enjoy taking ownership and accountability to drive continuous improvement of the quality system and work well both independently and in team settings. You can handle multiple tasks and manage priorities in a timely manner and have excellent collaboration and communication skills. You are analytical, detail- and result-oriented and can effectively combine flexibility with a strong decision-making ability. Importantly, you enjoy a dynamic place of work where people matter, and your contributions will make a positive impact. If you are passionate about making a difference in the lives of patients and have the skills and experience to excel in this role, we invite you to apply today! About Inossia AB Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care Inossia has completed a clinical study of 196 patients in 4 countries and 9 clinics Inossia received the Breakthrough Device Designation for Inossia Cement Softener in June 2025 To learn more, please visit www.Inossia.com For more information about the position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

New Terms AB

Quality Engineer to our client Are you an experienced quality engineer with a solid understanding of EU regulatory compliance and product certifications? We are now looking for a Quality Engineer for a consultancy assignment with an established international company with a strong digital presence and operations across multiple European markets. If you enjoy combining technical product knowledge with compliance work and supplier contact – this could be the assignment for you. About the assignment Our client is an international company with a strong market position, a broad product portfolio and operations in multiple countries. You will be responsible for quality assurance and product compliance for hard goods within a specific product category, with a focus on certifications and EU regulatory adherence. You will report to the QA & Compliance Manager and work closely with commercial teams, suppliers, logistics and internal stakeholders. Responsibilities Product compliance & certification Manage the certification process including validation of test reports and creation of Declaration of Conformity (DoC). Maintain documentation related to product compliance and EU regulations such as CE and EUDR. Quality assurance Identify root causes of quality issues, customer complaints and product-related claims. Manage product inspections and release goods for shipment. Ensure correct product labelling and creation of manuals and instructions. Product development & supplier contact Collaborate with commercial teams on new product developments through risk assessments, sample reviews and technical specification creation. Act as the main contact to suppliers regarding quality and compliance matters. Guidelines & internal support Maintain and update quality guidelines such as the Quality Manual when laws, standards or internal procedures change. Support internal teams with in-depth product knowledge on relevant standards, certifications and applicable processes. We are looking for someone who Is structured, analytical and detail-oriented with high professional integrity in supplier relations. You are self-organised, flexible and comfortable in an environment where processes and ways of working are continuously evolving. You have strong collaboration skills and are used to working cross-functionally with multiple internal and external stakeholders. Requirements & qualifications Degree in a relevant technical field such as Engineering, Product Development, Quality Management or Product Compliance – or equivalent experience Minimum 4–5 years of relevant experience within quality assurance, product compliance, certification or supplier quality management Experience with EU product compliance and applicable standards such as GPSR, REACH, RoHS, RED, Battery Regulation, WEEE, EUDR and PPWR Good knowledge of Microsoft Office (Excel, Word, PowerPoint) Strong problem-solving and analytical skills Strong cross-functional collaboration skills Meriting experience Experience from consumer products such as hard goods, electronics, PPE or other regulated product categories Experience with technical documentation, risk assessments and supplier quality processes Experience with Adobe Illustrator, Photoshop/InDesign or CAD software Location & scope Stockholm - 100% Application To apply for assignments via Jappa, you need to create a consultant profile on our platform and submit your application. By doing so, your profile will also become visible to other clients looking for commercial and specialist consultants for future assignments. Spend 10–15 minutes creating your profile today to be considered for exciting opportunities. We have replaced traditional recruitment with a smart marketplace, industry expertise, quality-assured processes and AI. The result is clearer matches, faster responses and happier consultants and clients alike. With Jappa, finding the right assignment is simple. We give you access to a wide range of opportunities within e-commerce and tech – from shorter freelance assignments to longer engagements and permanent roles. Jappa is a talent-as-a-service solution where you, as a consultant, are at the centre. We always strive to match you with assignments where you can truly make a difference and grow.

Boliden Mineral AB

Boliden is a high-tech metals company with its own mines and smelters that works long-term to guarantee society's access to base and precious metals. For a century, our work has been part of the value chains that have shaped modern society. At Boliden, we know that the metals we mine and make available will continue to play a crucial role in the future – what matters is how we produce them. Become a part of us and drive change for generations to come. Join us and shape the future of sustainable metals! Are you driven by the challenge of ensuring safety, sustainability, and technical excellence in dam safety and tailings management? As an Engineer of Record / Senior Dam Safety Engineer at Boliden, you will play a key role in developing a responsible and sustainable mining operation. Do you want to contribute to an industry that is shaping the world of tomorrow - you are welcome to submit your application today! Your opportunity As the Engineer of Record (EoR) / Senior Dam Safety Engineer for Our Somincor Tailings Storage Facilities in Portugal, you will play a pivotal role in safeguarding our tailings storage facilities (TSF) throughout their entire lifecycle — from design and construction to operation, closure, and post-closure. Who you will work with The role sits within the Dam Safety and Geotechnics department, part of the Sustainability function at Boliden Mines. You will join a knowledgeable and dynamic team responsible for ensuring the integrity and safety of Boliden’s TSFs. As EoR, you will collaborate closely with internal and external stakeholders to uphold the highest standards of engineering practice and regulatory compliance. The position is preferably based in Portugal (Site or our offices in Setubal) but can also be located at any of our operational sites. Regular travel to sites will be required, along with occasional visits to other Boliden locations. Remote work may be considered. What you will do As EoR for the Somincor TSF, you will work with facilities in different stages of their lifecycle. The Somincor TSF is in operation, but plans are being put in place to expand it to meet increased Lif of Mine storage requirement. You will therefore oversee design, construction, operation and the path to safe closure for the facilities. You will ensure compliance with regulatory and internal standards, including the Global Industry Standard on Tailings Management (GISTM). Your responsibilities include documenting engineering decisions, facilitating risk management implementation, reviewing and approving designs and construction documentation, and ensuring that monitoring and surveillance programs are implemented and effective. You will work closely with operations, environmental teams, senior leadership, as well as external consultants such as Designers of Record, third‑party reviewers, the Independent Tailings Review Board (ITRB), Independent Reviewers (IR), and regulatory authorities. You will also contribute to broader site-wide initiatives such as permitting, Life of Mine planning, and closure planning for the facilities. As part of the Sustainability staff, you will support the development of governance frameworks, provide technical guidance, and ensure high-quality documentation and reporting. This role is critical in ensuring safe and sustainable tailings management and directly supports Boliden’s commitment to responsible mining. What you bring A geotechnical or civil engineer with extensive experience in tailings and mine waste management or dam engineering. A strong background in geotechnical engineering, hydrology and dam safety, ideally with experience as Lead Designer, Designer of Record or Engineer of Record. Strong leadership capabilities and experience managing multidisciplinary projects. Excellent communication, interpersonal, writing, mentoring and presentation skills. Strong time management skills and the ability to engage with a wide range of stakeholders. Fluency in English is required; proficiency in Portuguese is considered a very strong asset. A valid EU Category B driving licence is required, as regular travel to our sites will be required. Why work with us At Boliden, we believe in promoting a workplace where care, courage, and responsibility are central to everything we do. We offer a workplace for professional growth and development, where we believe in collaboration and where what you contribute will have a direct impact on future generations. We are a company made up of responsible and creative people all working towards the same vision; to become the most sustainable and respected metal supplier in the world. About the TSFs More information about the TSFs you will be Engineer of record for can be found in our public disclosure documents at the following link Disclosures - Boliden Apply today to be part of something truly meaningful! At Boliden, diversity and inclusion are drivers of innovation. We know that different perspectives and experiences strengthen us and help us stay at the forefront of an important and exciting industry. Therefore, we encourage applications from people with diverse backgrounds and viewpoints. Together, we have built a workplace where everyone can feel safe and inspired to reach their full potential. Want to know more about the position? Contact hiring manager, Romain Girard, Romain.Girard@boliden.com, +46 70 405 75 66. Questions about the application are answered by our Talent Acquisition Partner, Pernilla Åkerblom, Pernilla.Akerblom@boliden.com, +46 73-023 69 61. For union information, please contact Mats Lindblom, SACO, +46 73-350 04 19, Andreas Mårtensson, Unionen, +46 70-541 83 93 or Peter Markström, Ledarna, +46 910-77 40 09. Welcome to submit your application no later than July 26, 2026. As part of Boliden’s qualitative recruitment efforts and systematic safety work, background checks will be included in the recruitment process. If you are a representative of a recruiting company, please refrain from contacting us about this advertisement. We appreciate your consideration.