Manager Regulatory Affairs Submission (f/m/d)
Manager Regulatory Affairs Submission (f/m/d)
<body> <h1>Manager Regulatory Affairs Submission (f/m/d)</h1> <h2>PAUL HARTMANN AG, Heidenheim</h2> <p> Helps. Cares. Protects. At HARTMANN, we're all in to help , care , protect and grow . We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as Manager Regulatory Affairs Submission (f/m/d) DEU-Heidenheim As part of the Regulatory Affairs team, we offer you an exciting and responsible role in a globally active functional area. We enable our employees to get involved in interesting tasks in a modern field of work and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we should definitely get to know each other. Responsibilities: In this role, you will act as a competent regulatory contact for business units, regions and international sales partners with regard to the global submission management of our product portfolio You will be responsible for managing the necessary submission documents with a focus on countries outside the European Union / EFTA You coordinate the submission activities with your global colleagues and sales partners Furthermore, you will accompany and monitor the submission process from the application to the approval received As part of the global RA team, you will share your best practices and engage in close professional dialogue Qualification: Successfully completed a university degree in a scientific or technical field or comparable You have initial experience in regulatory affairs in the medical devices environment Ideally knowledge or experience in submission processes for medical devices on a global basis Knowledge of the regulatory requirements for medical devices, e.g. Regulation (EU) 2017/745, ISO13485 Enjoy working in an international team Fluent in English and good knowledge of German is an advantage Benefits: Flexible working conditions, such as flexible working hours and mobile working International Mobile Working Attractive ways of combining work and family life, e.g. childcare subsidy 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement Company pension plan with attractive employer contribution incl. matching model for deferred compensation Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass) Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc. Job Bike Leasing Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform Shape a career that's focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform. Your personal contact: Isabel Proske Apply now » </p> </body>