R&D Safeguarding Team Leader R&D Department (Medical Devices)

Do you want to be part of a team that is committed and passionate about knowledge and challenges? Do you want to work in a learning and cooperative environment? Do you want to contribute with your work to improve the lives of patients? 

Role Purpose 

An opportunity has arisen for a self-driven and committed R&D Safeguarding Team Leader to join a multinational Medical Device company. Reporting to the Head of R&D Safeguarding, your mission will be to be responsible for the coordination of 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

• Coordinates and leads the management activities of the assigned team, regularly reviewing and adjusting plans, setting challenging goals and focusing on priorities. 
• Defines the objectives of the team members, ensuring the development of the appropriate competency profile for the correct performance of the responsibilities assigned.
• Accountable for evaluating decisions that help the team handle the triple constraint (time, scope, resources) and for appropriate resolution of challenges.
• Provides 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.
• Communicates progress, risks and resources needs to the Head of R&D Safeguarding area.
• Promotes and ensures strong collaboration across R&D, Regulatory Affairs, Quality, Operations, and other company department areas.
• Participates as a Project Team Leader when appropriate, promoting a strong collaborative and partnership approach with the B. Braun Project Management Office (PMO).
• Defines, coordinates and oversees the execution of project plans to ensure the correct implementation according to the required standards, deadlines and budgets.
• Coordinates studies and tasks related to R&D projects based on Product Life Cycle Management ensuring compliance with the objectives and deadlines (i.e. product and packaging verification and validation studies, dual sourcing studies, production transfers, production capacity increase studies, discontinuations).
• Participates in multidisciplinary projects of the company in which the contribution to the team providing data, technical support and/or know-how may be necessary.
• Collaborates on the quality aspects of B. Braun products when appropriate (e.g. definition of raw material, intermediate or finished product specifications, product requirements like storage or transport conditions, etc.).
• Technical involvement in the development of the relevant product/process documentation in the context of ISO 13495 certified quality management system (i.e. specifications, standard operating procedures, product risk analysis).
• Leads and/or participates in the required Change Controls in products, processes and the quality management system.
• Collaborates with the Regulatory Affairs department in the preparation and update of the Technical Dossier for the European and international registries.
• Participates in the response strategy to competent authorities in regulatory processes and responds to questions submitted by the European notified bodies, FDA, NMPA, PMDA and other international regulatory agencies.
• Participates in internal and external audits of competent regulatory authorities.
• Training of R&D staff and/or other areas within the CoE or the Group, to strengthen internal expertise and foster collaboration between areas, both locally and globally.
• Collaboration with other areas of the CoE or the Aesculap Division, promoting the 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.
• Previous experience of 3 to 5 years in in positions like the one offered.
• Solid knowledge of Medical Devices Industry with in-depth knowledge of the 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 are willing to contribute to the goals.
• You think logically, analytically, and systematically, being at the same time proactive, with a practical approach, resolutely and with decision-making ability.
• You are organized, knows how to plan to meet the defined deadlines pursuing quality standards appropriate to the objective and can deal with competing priorities.
• You are a detailed-oriented person.
• You have excellent communication and organizational skills.
• You are a team player, and you are willing to integrate into a high-performance team.
• You are excited about knowledge, and autonomous learning motivates you.
• You are proactive and self-driven person.
• You can foster a culture of cross team collaboration
• You adapt to change and are open to the development of 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