Cochlear Bone Anchored Solutions AB jobb

Job Overview & Purpose: The Director Clinical Portfolio Strategy reports to the Director Clinical Design and Strategies and is responsible for leading a team of Clinical Development Managers and Clinical Research Audiologists. The team will deliver Clinical Evidence Strategies, study designs, and study documentation for Cochlear product portfolios. This role will also provide subject matter expertise to product design and execute in-house clinical investigations to support business needs. The Director will bring clinical and scientific expertise into the portfolio domain, driving clinical science and understanding unmet clinical needs to contribute to commercial solutions and strategy definition. Additionally, the Director will be a key contributor to roadmap forward planning for the integration of emerging technologies. Key Responsibilities: Drive Clinical Evidence Strategy and Plan: * Lead a team to develop a comprehensive Clinical Evidence Strategy and Plan (CESP) for products and systems within the Portfolio area. * Ensure processes and forums exist to communicate CESPs and planned evidence activities. * Assimilate key inputs from Clinical and represent the function as the consistent point of contact for the Portfolio. * Develop, maintain, and communicate scenario plans for the Portfolio. * Close knowledge gaps through literature reviews, data collation, and analyses. Maintain and Enhance Cross-Functional Collaboration: * Promote a culture of cross-functional collaboration as input to clinical strategy and product design. * Partner with GSM to contribute to desired claims and evidence needs to support key markets. * Work in partnership with R&D to ensure Clinical representation and input at appropriately defined timepoints and milestones throughout the Product Innovation Process (PIP). Lead Development of End-to-End Evidence Strategy: * Lead the development of an aligned end-to-end strategy for the evolution of the Acoustics portfolio. * Ensure efficient and effective transfer of evidence and knowledge from Advanced Innovation to the Portfolio. * Drive the clinical science for the portfolio, identify gaps and ambiguity in knowledge and evidence. Drive Planning and Delivery of Overall Portfolio Strategy: * Plan at Portfolio level to ensure appropriate resource allocation. * Oversee and develop study documentation to ensure compliance with GCP and business processes. * Lead or support the team in discussions with internal stakeholders to develop study design concepts. Effectively Communicate Clinical Plans: * Communicate and advocate for the lifetime portfolio strategy across cross-functional project teams. * Ensure that the clinical portfolio strategy and research priorities are well understood and aligned with the needs of the evidence to be gathered and the studies to be undertaken. Integrate Clinical Audiology and Clinical Portfolio Functions: * Ensure team members are allocated to projects in line with their expertise and business needs. * Identify gaps and opportunities for the Clinical Audiology function to optimally support product design. * Strengthen networks and communication mechanisms between CSI Clinical Audiology teams and regional audiology and ClinTech teams. Team Role: * Actively promote the quality management system and ensure that all staff are trained. * Build capability of people managers and their teams to attract, develop, and retain top talent. * Demonstrate WH&S leadership and ensure that people are suitably trained to perform jobs effectively and safely. Minimum Key Incumbent Requirements: * 10 years of experience in clinical research within the medical device sector or relevant field. * Demonstrable exposure to commercial business needs and experience in balancing needs of internal stakeholders. * An Enterprise mindset with the ability to see the "big picture". * Resilient, resourceful, and solutions-oriented. * Demonstrated ability in managing people and creating a positive working environment. Desired Skills: * Bachelor degree or higher in a scientific or healthcare discipline. * Experience in development of clinical strategies and in study design and reporting. * Thorough understanding of international aspects of device development process. * Familiar and comfortable with FDA, TUV Sud or equivalent Notified Body, and TGA regulations. * Clear and effective communicator with well-developed report and technical writing skills. * Familiar with data management and interpretation methods. * Comfortable with regular travel as deemed appropriate. Certifications: * PhD or tertiary qualification in Audiology. * Experience in hearing care setting or industry. * Leadership of a globally dispersed clinical research team in either pharmaceuticals or medical devices. * Familiar and comfortable with clinical concepts and practices in the field of hearing. Education: * PhD or tertiary qualification in Audiology. Languages: * English - Fluent.

Job Overview: We are looking for a Verification and Validation Engineer to ensure our products meet quality standards and performance criteria. This role also involves contributing to the product lifecycle engineering process and involves working on sound processors, new products, test systems, and accessories. Key Responsibilities: * Develop and execute verification and validation activities. * Deliver technical documentation. * Stay updated on best practices and act as a Subject Matter Expert. * Provide technical leadership to Engineers. * Coordinate project and product lifecycle engineering deliveries. * Identify and recommend improvements to operational procedures. * Ensure project and product lifecycle engineering tasks are delivered in accordance with design control within the Quality Management System. Required Skills: * Understanding of verification and validation principles for medical device development. * Good communication, writing, and presentation skills. * Problem-solving and collaboration abilities. * Analytical thinking and a quality mindset. Desired Skills: * Experience in a medical device company or other regulated industry. * Knowledge of common measuring and test methods. * Acoustics measurement experience. * Experience in test systems development. * Product design or project coordination experience. Education: * Engineering/Science Degree or similar. Languages: * Fluent in English. Work Experience: * Minimum of 3 years of specialist technical knowledge and/or experience.

Job Overview: We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our team. This role is crucial in providing regulatory support throughout the lifecycle of Cochlear products. The Senior Regulatory Affairs Specialist will work closely with R&D cross-functional project teams, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements. Key Responsibilities: * Regulatory Strategy and Planning: Support project teams with regulatory and standards compliance advice through product development. Define documentation needs and ensure they are delivered to quality and timeline requirements. Develop regulatory strategies in collaboration with regional regulatory teams, to support business plans for products or projects. Participate in strategic regulatory and continuous improvement projects as required. * Regulatory Submissions and Related Activities: Prepare and manage the submission process to gain new or modified product approvals and maintain product licenses. Adapt or create technical dossiers for regional market submissions and coordinate support for regional subsidiaries, offices, and distributors. Ensure timely regulatory assessments of sustaining changes, including submissions or the necessary documentation of them (e.g. Letter to File). * Cross-Functional Regulatory Direction: Evaluate labeling and manufacturing changes and promotional material for regulatory impact. Provide regulatory direction to the business and inform the organization about new or changing national regulations/trends and propose implementation plans. Drive the implementation of better regulatory practices and processes. Qualifications: * Proven experience in regulatory affairs, including management, compilation, submission, and maintenance of regulatory filings. * Strong skills in influencing in a matrix team environment and managing stakeholders at all levels within the business. * Ability to make judgments and provide advice that balances business interests and regulatory risk. * Excellent review, report writing and documentation skills. * Knowledge of global regulatory requirements and regulations for medical devices, with an emphasis on MDR. Certifications: * Regulatory Affairs Certification (RAC) is highly desirable. Education: * Minimum Bachelor's degree in engineering, legal, scientific, or healthcare; or 3+ years' experience in software or product development, quality, and/or regulatory affairs. Languages: * English - Advanced/Fluent. Work Experience: * 3+ years' experience in regulatory affairs, including a track record of management, compilation, submission, and maintenance of regulatory filings. * 3+ years' experience in medical devices product or software development (SaMD). * Ideally worked in a global matrix organization including manufacturing and logistics.

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.