Overview
R&D Saf safeguarding Team Leader (Medical Devices)
Be among the first to apply. An opportunity has arisen for a self-driven and committed R&D Saf safeguarding Team Leader to join a multinational Medical Device company. Reporting to the Head of R&D Saf safeguarding, your mission will be to coordinate all R&D activities related to products currently on the market, ensuring quality and compliance with international standards and regulations.
Role Purpose
An opportunity has arisen for a self-driven and committed R&D Saf safeguarding Team Leader to join a multinational Medical Device company. Reporting to the Head of R&D Saf safeguarding, your mission will be to coordinate all R&D activities related to products that are currently on the market ensuring quality and compliance with international standards and regulations.
Obligations And Responsibilities
* Coordinate and lead the management activities of the assigned team, regularly reviewing and adjusting plans, setting challenging goals and focusing on priorities.
* Define the objectives of the team members, ensuring the development of the appropriate competency profile for the correct performance of the responsibilities assigned.
* Be accountable for evaluating decisions that help the team handle the triple constraint (time, scope, resources) and for appropriate resolution of challenges.
* Provide the team with support, technical supervision, guidance, and expertise, ensuring compliance with best practices and methodologies, guaranteeing that goals and objectives are defined, understood, and met, and that the strategy is properly addressed and supported.
* Communicate progress, risks and resources needs to the Head of R&D Safeguarding area.
* Promote and ensure strong collaboration across R&D, Regulatory Affairs, Quality, Operations, and other company departments.
* Participate as a Project Team Leader when appropriate, promoting a strong collaborative and partnership approach with the B. Braun Project Management Office (PMO).
* Define, coordinate and oversee the execution of project plans to ensure correct implementation according to required standards, deadlines and budgets.
* Coordinate studies and tasks related to R&D projects based on Product Life Cycle Management ensuring compliance with objectives and deadlines (e.g., product and packaging verification and validation studies, dual sourcing studies, production transfers, production capacity increases, discontinuations).
* Participate in multidisciplinary projects, providing data, technical support and / or know-how as needed.
* Collaborate on the quality aspects of B. Braun products (e.g., material specifications, product requirements like storage or transport conditions).
* Contribute to development of product / process documentation in the context of ISO 13485 quality management system (e.g., specifications, standard operating procedures, product risk analysis).
* Lead and / or participate in Change Controls for products, processes and the quality management system.
* Collaborate with Regulatory Affairs in preparing and updating the Technical Dossier for European and international registries.
* Participate in regulatory response strategies to authorities and respond to questions from European notified bodies, FDA, NMPA, PMDA and other agencies.
* Participate in internal and external audits of regulatory authorities.
* Train R&D staff and / or other areas within the CoE or Group to strengthen internal expertise and foster collaboration.
* Collaborate with other areas of the CoE or Aesculap Division to promote exchange of best practices and tools for continuous improvement.
Professional competencies
* Bachelor's degree in Life Sciences, Chemistry, Chemical Engineering, Materials Engineering, Industrial Engineering, Biomedical Engineering, or another relevant technical discipline is required.
* 3 to 5 years of related experience.
* Solid knowledge of Medical Devices Industry with in-depth knowledge of FDA, EU MDR and other global medical device regulations and / or biological regulations, ISO 10993, 14971 and 13485 series.
* Competence in using statistical tools for data analysis and trends.
* Full professional competence in English.
* High level of proficiency in MS Office software.
Personal competencies
* You are responsible, committed, and willing to contribute to the goals.
* You think logically, analytically, and systematically, being proactive with a practical approach, resolute in decision-making.
* You are organized, able to plan to meet deadlines, pursuing quality standards appropriate to the objective and able to manage competing priorities.
* You are detail-oriented.
* You have excellent communication and organizational skills.
* You are a team player and willing to integrate into a high-performance team.
* You are excited about knowledge, and autonomous learning motivates you.
* You are proactive and self-driven.
* You foster a culture of cross-team collaboration.
* You adapt to change and are open to developing new skills to face challenges.
* You have a positive attitude towards challenges.
If you are passionate about the role and believe you would be a great fit, we would love to hear from you.
B. Braun Surgical, S.A.U. | Victoria Merodio
Seniority level : Mid-Senior level
Employment type : Full-time
Job function : Research, Analyst, and Information Technology
Industries : Medical Equipment Manufacturing
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