Regulatory Affairs Specialist I

Job Summary
Join Fresenius Kabi as a Regulatory Affairs Specialist in our TCT (Transfusion Medicines and Cell Therapy) Division.
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. This position will be supporting the Solutions Team within Regulatory Affairs.
Responsibilities

• Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets
• Gather design and development information on products from cross-functional teams and submit on-time annual reports and renewal applications to maintain existing registrations worldwide
• Help develop local and international submission strategies 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 a regulatory strategy for implementation of such changes
• Conduct research on applicable and changing regulations, product standards and guidance documents issued by health authorities worldwide and determine impact to products and projects
• Support the senior staff in a variety of capacities with ongoing development and sustaining projects
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• Bachelor's Degree preferred with at least 1-2 years of experience in a function such as regulatory, quality, or clinical in the life sciences industry. High School Diploma and at least 3 years of relevant technical experience in a regulatory function may be considered.
• Well-developed oral and written communication skills
• Great team player showcasing ability to work in a collaborative culture and matrix environment
• Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
• Ability to portray critical thinking to understand complex information and convert/communicate it in a comprehensible manner
• Ability to organize data packages in a clear and concise manner to enable smooth reviews of scientific information by internal and external stakeholders
• Ability to manage multiple projects and deadlines and prioritize effectively
• Experience in evaluating information to determine compliance with standards, laws, and regulations
• Knowledge of at least one foreign language preferred

Additional Information
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, citizenship, immigration status, disabilities, or protected veteran status.