This position provides the opportunity to develop your skill set as an effective regulatory professional in a large medical device division specializing in medical technologies for transfusion and cell therapies. The successful candidate can look forward to professional growth within the organization.
Collaborate with international colleagues to generate high quality submission dossiers to obtain medical device approvals in international markets. •Gather design and development information on products from cross-functional teams and submit on-time renewal applications to maintain existing registrations worldwide. •Develop regulatory strategies for countries outside of U.S to ensure speed to market while maintaining high standards of quality. •Assess global impact of product changes such as manufacturing, design, materials, technology, labeling etc. to determine course of action and develop regulatory strategy for implementation of such changes. •Conduct research on applicable product standards and guidance documents issued by health authorities worldwide and determine impact of proposed and current global regulations to propose suggestions for expediting approvals. •Support the senior staff in a variety of capacities with ongoing development projects.
•Ability to grasp new concepts quickly and to assimilate and evaluate scientific data. •Great team-player showcasing ability to work in a collaborative culture •Flair for scientific writing with meticulous attention to detail •Portray critical thinking to understand complex information and convert/communicate it in a comprehensible manner •Organize data packages in a clear and concise manner to enable smooth reviews of scientific information by external stakeholders •Ability to manage multiple projects and deadlines and communicate priorities effectively •Experience evaluating information to determine compliance with standards, laws, and regulations •Well-developed oral and written communication skills •Bachelor's Degree or equivalent in Scientific discipline (e.g., Biology, Chemistry, Engineering, Information Technology, pharmacology, clinical sciences or other relevant fields) OR 3+ years of relevant industry experience
The following experience/ related coursework is desired and a plus:
•Experience in preparing domestic and international product submissions •Knowledge of US, EU and international regulatory requirements •Experience with design and development of medical devices •Knowledge of at least one foreign language is a plus
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Internal Number: LZD00318
About Fresenius Kabi USA, LLC
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.