Job objective:

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.

Tasks and Responsibilities:

• Acts as the GRA contact person for assigned country-specific regulatory requirements.
• Manages and prepares the documentation required to obtain and maintain ORS product registrations internationally (RoW), including both existing and newly developed medical devices.
• 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.
• Ensures correct application of product labeling requirements and collaborates with Global Regulatory Affairs for label updates when required.
• Provides internal and external advice on registration procedures, regulatory requirements, and potential impacts on product design.
• Maintains effective communication with colleagues from GRA, related departments, local representatives (LRA), and relevant stakeholders.
• Interpretation of specific countries’ regulations applicable to specific medical devices.
• Performs gap analyses of assigned regulations and standards, ensuring timely identification of necessary actions.

• Plans and prepares the implementation of assigned product changes generated through the Change Control System, in collaboration with Global Regulatory Affairs and related departments.
• Gathers information on the impact of product changes according to the registration status in the countries under his/her responsibility.
• Assesses the global impact of product changes in collaboration with local Regulatory Affairs teams, considering documentation available in the RMF in B.Docs.
• Prepares and submits the required documentation for change notifications to LRAs or competent authorities (if applicable).
• Monitors the progress and outcomes of global notifications and registrations, ensuring updates are reflected in internal databases.
• Manages all activities derived from the Change Control process.

• 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.

• Participates in GRA projects focused on process improvement within the department.
• Contributes to lessons-learned activities and continuous improvement initiatives.
• Documents projects, tasks, progress, and deadlines in accordance with internal procedures.
• Manages delegated specific RA tasks and projects assigned.

• Shares the expertise and provides job shadowing to the new colleagues and supports colleagues taking on new responsibilities.
• Ensures compliance with the company’s “Code of Conduct”.

Professional competencies / Ideal candidate:

• Master’s/ bachelor’s degree in Pharmacy, Biology or Chemistry preferred.
• At least 2 years of Experience in Regulatory Affairs within the Medical Devices industry, working in cross-functional teams.
• Knowledge of Medical Devices European regulation, in particular EU MDR (2017/745)
• Knowledge of country specific regulations for medical devices will be valued positively.
• English - advanced, written and spoken;
• Proficient in MS Office applications, Outlook, Adobe Professional / Nuance;
• SAP – advantage.
• Good documentation practice for easy access and future reference.

Personal Competencies

• High capacity of solving problems to achieve positive results;
• High organizational skills: ability of multitasking, task prioritization, transparency, attention to detail;
• High level of personal responsibility and commitment, capable of fast learning and adopting new systems;
• Ability to work in cross functional teams, excellent communication, flexibility and resilience;
• High ethical values;
• Intercultural skills – advantage;
• Willing to travel internationally.

Personal Competencies

• High capacity of solving problems to achieve positive results;
• High organizational skills: ability of multitasking, task prioritization, transparency, attention to detail;
• High level of personal responsibility and commitment, capable of fast learning and adopting new systems;
• Ability to work in cross functional teams, excellent communication, flexibility and resilience;
• High ethical values;
• Intercultural skills – advantage;
• Willing to travel internationally.

Benefits:

• Unlimited period contract;
• Annual performance bonus;
• Hybrid working mode - working from home in a proportion of 50-60% – Office work takes place in Sânandrei, Timis County;
• Meal tickets;
• Health subscription (free or discounted medical services);
• 7 Card subscription;
• A premium for family events, according to the Collective Labor Agreement;
• Partial settlement costs for the purchase of eyeglasses;
• Free coffee and dynamic work atmosphere.

B. Braun Shared Services Romania | Adriana Nai | +40256214991