Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Education and Experience:
Summary: This role's primary purpose is for ensuring that assigned devices, associated labeling, and packaging are designed to be safe and effective for use by intended users.
Essential Duties and Responsibilities include, but are not limited to, the following:
*Lead Human Factors activities within Combination Product Development: author study protocols, contribute to product design and design control activities, supervise vendor-led studies, etc.
*Develop of Instructions for Use, Manuals, packaging design, and other usability/design-related graphics.
*Design and ensure full change control for IFU and labeling documentation where applicable for assigned projects.
*Oversee project management activities with vendors, partners, and internal departments.
*Provide HF study feedback and/or recommended mitigation actions to the project teams.
*Translate complex product information into concise, compliant, easy-to-follow instructions for use.
*Degree in Human Factors, Graphic Design/Visual Design, Industrial Design, or a related field;
oWith either a Master's degree in one of the above fields from an accredited university and a minimum of two years of relevant industry experience, or a Bachelor's degree and a minimum of four years of relevant industry experience.
*Familiarity with Adobe Acrobat, Illustrator, InDesign, Photoshop, and vector graphics software (e.g. Adobe Illustrator) is a must.
*Understanding of FDA medical device regulations, design controls, and Good Manufacturing Practices (GMP) is strongly preferred.
*Understanding of project labeling development in a regulated industry is strongly preferred.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.