Jr RA/QA Associate

Job Description Job Description The Junior Quality/Regulatory Affairs Associate under the direction of the VP of Quality and Regulatory Affairs will be responsible for assisting in the organization and management of the quality affairs activities including the development and organization of quality documents and preparation for both internal and external audit activities. The Junior Quality/Regulatory Affairs Associate will also assist Regulatory Affairs in producing and organizing MDR documents or product reports to FDA and Health Canada. The successful candidate will be trained to assist the department management in the oversight of the company’s submissions to the FDA and international regulatory authorities. Exposure to Audit Processes, as well as HDE, PMA and 510K submissions is desirable. ESSENTIAL FUNCTIONS AND BASIC DUTIES The duties of Junior Quality/Regulatory Affairs Associate for North America are to include assisting with: Daily quality activities Development and organization of quality documents Internal and external audits Maintaining adherence to the established Quality System Maintaining facility compliance to the Quality Policy and all other external regulatory standards. Maintaining compliance for safety reporting Regulatory activities for North America and the preparation of US Regulatory Submissions Maintaining the necessary files to assure FDA compliance Identifying potential risk areas The review product changes and their impact upon regulatory submissions Interacting with R&D, QA, Manufacturing, Logistics, Clinical Affairs, Sales, Marketing, external consultants, and notified bodies. QUALIFICATIONS: EDUCATION: Bachelor/Master of Science in related field of study with exposure to medical devices. REQUIRED KNOWLEDGE : Knowledge of quality systems, processes, and documentation, product development and change implementation, MDR determination. REQUIRED ABILITIES: Excellent organizational skills, strong strategic and analytical competence, open-minded, flexible, “hands-on” and proactive, self-starter, dynamic, enthusiastic with a strong business drive, to communicate, drive and actively work in teams with a strong focus on implementation, to work within a multicultural environment, strong oral and written communication skills, collaboratively works with others, and operate ethically and with integrity Company Description Berlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The Berlin Heart portfolio of ventricular assist devices offers you the ability to treat your patients with uni- or biventricular support as bridge to recovery and bridge to transplantation. EXCOR Pediatric is clinically reliable for support times of a few days up to several years as well as supports pediatric patients of all ages, from newborns to adolescents, with outstanding clinical performance proven in over 2,300 pediatric patients worldwide. Company Description Berlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The Berlin Heart portfolio of ventricular assist devices offers you the ability to treat your patients with uni- or biventricular support as bridge to recovery and bridge to transplantation. EXCOR Pediatric is clinically reliable for support times of a few days up to several years as well as supports pediatric patients of all ages, from newborns to adolescents, with outstanding clinical performance proven in over 2,300 pediatric patients worldwide.