We are seeking an experienced Senior Design Manager to join an ambitious international project based in Stockholm. This role involves working within a large-scale initiative that brings together multiple global suppliers and contractors. As Design Manager, you will be responsible for leading, planning, and coordinating design deliveries to ensure high-quality and consistent outcomes. Your ability to navigate cultural and organizational differences, while driving and overseeing design processes, will be key to the project’s success. Key Responsibilities Design Management • Develop and implement a clear design strategy aligned with project objectives. • Collaborate with QA, Document Control, Requirement Management, and Information Management teams to establish and oversee the technical document review process. • Ensure that design processes and outputs align with international standards and regulatory requirements. • Define responsibilities for technical reviews, track feedback implementation, and ensure timelines and milestones are met. • Work alongside the Interface Manager and Engineering Discipline Leads to manage cross-discipline interfaces and ensure timely technical deliverables. • Contribute to the overall project strategy by proposing innovative and sustainable design solutions. Coordination & International Collaboration • Coordinate design activities across multiple regions, considering local conditions and business objectives. • Foster strong relationships with international suppliers and contractors to maintain consistency and high quality in design deliverables. • Enhance communication and collaboration between global and local teams, ensuring all stakeholders work towards unified goals. • Oversee the scheduling of all design activities, ensuring the right stakeholders conduct reviews and that suppliers/contractors implement necessary modifications. • Ensure the timely and synchronized delivery of design packages, monitoring adherence to agreed timelines. Quality Assurance & Standards • Ensure compliance with local regulations, industry standards, and agreed methodologies in all design work. • Review and approve design solutions, maintaining consistency and quality across the project. • Work closely with the Information Lead to introduce tools and methodologies that enhance collaboration and quality assurance in a global environment. • Participate in the Change Management Council, as needed. Communication & Cultural Awareness • Act as a central communication hub between international teams and project leadership, ensuring clarity and efficiency. • Leverage intercultural skills to foster trust and collaboration among diverse stakeholders. • Communicate design strategies and solutions to both global and local teams in a way that aligns with their specific needs and perspectives. Leadership & Team Development • Lead and develop a diverse, international design team, ensuring alignment with project objectives. • Provide the necessary resources and skill development opportunities to support team performance. • Foster an inclusive and motivating work environment that drives engagement and collaboration. Additional Details • Working language: English • Travel requirements: Regular national and international travel, with frequent (weekly or biweekly) trips to Milan for 2–4 days per visit. • On-site presence: Required at the Stockholm project office at least three days per week, subject to project needs. • Reporting to: Engineering Manager or another senior leader within the project structure. • Collaboration with: Project management, work package leads, engineering managers, discipline leads, and both local and international contractors and suppliers. Requirements • Experience as a Senior Design Manager. • Fluent in English, both spoken and written. Start Date and Application Start: April 1, 2025 End: December 31, 2026 Deadline: ASAP Location: Stockholm Contact Person: 0790 062 711 Selections and interviews are ongoing! Sway Sourcing is an innovative recruitment partner specializing in matching the right talent with the right company – quickly and efficiently. Our main focus areas include Finance, Administration, HR, Marketing, and IT, but we also have the broad expertise and flexibility required to deliver tailored recruitment solutions across all industries. Although we are a relatively new player, we have already gained the trust of many of Sweden’s largest companies and operate both nationally and internationally. With bases in Sweden and Spain, we offer a unique combination of local expertise and global reach. Our strong network and deep industry insights make us a natural partner for companies looking to stay ahead in their recruitment efforts.

Are you a seasoned professional in Regulatory Affairs looking to make a significant impact on a global scale? Cochlear Limited, a leader in implant, sound processor, and acoustics products, is seeking a dynamic Director of Regulatory Affairs. In this pivotal role, you will lead our CBAS Regulatory team based in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide. Your leadership will drive cross-functional partnerships and alignments, contributing to our mission of transforming lives. Key Responsibilities: Strategic Leadership: * Shape and execute global regulatory strategies. * Mentor and guide your team to provide critical regulatory insights for Cochlear's Product Innovation Process (PIP). * Present strategic recommendations to CBAS leaders and Regional Regulatory teams. * Oversee multiple high-priority projects, ensuring successful outcomes. * Forge strong relationships and negotiate with external regulatory bodies. * Communicate effectively with all stakeholders to foster teamwork and alignment. * Deliver impactful business and technical briefings to key stakeholders. Operational Excellence: * Develop and optimize systems for tracking regulatory submissions and commitments. * Lead the team in managing change controls and submission requirements. Regulatory Compliance: * Serve as the appointed "Person Responsible for Regulatory Compliance" (PRRC). * Review and approve labelling materials. * Address European regulatory requirements for recalls and adverse event filings. * Participate in regulatory audits and inspections. * Maintain QMS procedures related to Regulatory Affairs. Team Development: * Attract, develop, and retain top talent to achieve Cochlear's business objectives. * Provide regular feedback and coaching to foster growth and success. * Champion workplace health and safety initiatives. Key Requirements: Minimum: * Bachelor's degree in a related field with extensive experience in Regulatory Affairs. * Knowledge of at least two medical device jurisdictions (e.g., FDA, TGA, EU MDR). * Proven experience in healthcare, regulatory affairs, and medical devices. * Expertise in financial mechanisms and budget management. * Demonstrated ability to lead teams and collaborate with People and Culture. * Exceptional attention to detail and proficiency in English. * Ability to thrive in a fast-paced, dynamic environment. Ideal: * Master's degree in a related field. * Strong negotiation and influencing skills for optimal commercial outcomes. * RAPs certification.