About this role
<p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Job objective:</span></strong></p> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><span style="line-height:115%">GRA (Global Regulatory Affairs) MD (Medical Devices) Junior Manager supports Global Regulatory Affairs - B. Braun Surgical, with medical devices’ registrations and corresponding life cycle activities.</span></p> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Tasks and Responsibilities:</span></strong></p> <ul> <li style="line-height:115%"><span style="line-height:115%">Acts as the GRA contact person for assigned country-specific regulatory requirements.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Manages and prepares the documentation required to obtain and maintain ORS product registrations internationally (RoW), including both existing and newly developed medical devices.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Formulates responses to regulatory authority deficiency letters and to requests from local collaborators (LRA – Local Regulatory Affairs) in the context of product changes or registrations.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Ensures correct application of product labeling requirements and collaborates with Global Regulatory Affairs for label updates when required.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Provides internal and external advice on registration procedures, regulatory requirements, and potential impacts on product design.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Maintains effective communication with colleagues from GRA, related departments, local representatives (LRA), and relevant stakeholders.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Interpretation of specific countries’ regulations applicable to specific medical devices.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Performs gap analyses of assigned regulations and standards, ensuring timely identification of necessary actions.</span></li> </ul> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Plans and prepares the implementation of assigned product changes generated through the Change Control System, in collaboration with Global Regulatory Affairs and related departments.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Gathers information on the impact of product changes according to the registration status in the countries under his/her responsibility.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Assesses the global impact of product changes in collaboration with local Regulatory Affairs teams, considering documentation available in the RMF in B.Docs.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Prepares and submits the required documentation for change notifications to LRAs or competent authorities (if applicable).</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Monitors the progress and outcomes of global notifications and registrations, ensuring updates are reflected in internal databases.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Manages all activities derived from the Change Control process.</span></li> </ul> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Works closely with the Person Responsible for Regulatory Compliance (PRRC) in preparing notifications and communications to health authorities, and in markets notification processes, where applicable.</span></li> </ul> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Participates in GRA projects focused on process improvement within the department.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Contributes to lessons-learned activities and continuous improvement initiatives.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Documents projects, tasks, progress, and deadlines in accordance with internal procedures.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Manages delegated specific RA tasks and projects assigned.</span></li> </ul> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Shares the expertise and provides job shadowing to the new colleagues and supports colleagues taking on new responsibilities.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Ensures compliance with the company’s “Code of Conduct”.</span></li> </ul> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Professional competencies / Ideal candidate:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Master’s/ bachelor’s degree in Pharmacy, Biology or Chemistry preferred.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">At least 2 years of Experience in Regulatory Affairs within the Medical Devices industry, working in cross-functional teams.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Knowledge of Medical Devices European regulation, in particular EU MDR (2017/745)</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Knowledge of country specific regulations for medical devices will be valued positively.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">English - advanced, written and spoken; </span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Proficient in MS Office applications, Outlook, Adobe Professional / Nuance;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">SAP – advantage.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Good documentation practice for easy access and future reference.</span></li> </ul> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Personal Competencies</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High capacity of solving problems to achieve positive results;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High organizational skills: ability of multitasking, task prioritization, transparency, attention to detail;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High level of personal responsibility and commitment, capable of fast learning and adopting new systems;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Ability to work in cross functional teams, excellent communication, flexibility and resilience;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High ethical values;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Intercultural skills – advantage;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Willing to travel internationally.</span></li> </ul> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Personal Competencies</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High capacity of solving problems to achieve positive results;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High organizational skills: ability of multitasking, task prioritization, transparency, attention to detail;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High level of personal responsibility and commitment, capable of fast learning and adopting new systems;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Ability to work in cross functional teams, excellent communication, flexibility and resilience;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">High ethical values;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Intercultural skills – advantage;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in"><span style="line-height:115%">Willing to travel internationally.</span></li> </ul> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"> </p> <p style="margin:0.0in;line-height:115%"><strong><span style="line-height:115%">Benefits:</span></strong></p> <ul> <li style="line-height:115%"><span style="line-height:115%">Unlimited period contract;</span></li> <li style="line-height:115%"><span style="line-height:115%">Annual performance bonus;</span></li> <li style="line-height:115%"><span style="line-height:115%">Hybrid working mode - working from home in a proportion of 50-60% – Office work takes place in Sânandrei, Timis County;</span></li> <li style="line-height:115%"><span style="line-height:115%">Meal tickets;</span></li> <li style="line-height:115%"><span style="line-height:115%">Health subscription (free or discounted medical services);</span></li> <li style="line-height:115%"><span style="line-height:115%">7 Card subscription;</span></li> <li style="line-height:115%"><span style="line-height:115%">A premium for family events, according to the Collective Labor Agreement;</span></li> <li style="line-height:115%"><span style="line-height:115%">Partial settlement costs for the purchase of eyeglasses;</span></li> <li style="line-height:115%"><span style="line-height:115%">Free coffee and dynamic work atmosphere. </span></li> </ul> <p style="line-height:115%"> </p><p>B. Braun Shared Services Romania | Adriana Nai | +40256214991 </p>