Title:  Specialist, Regulatory Affairs, Human Factors

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

The Specialist, Regulatory Affairs will be responsible for applying human factors and usability engineering methods throughout the design and development processes for West’s Products including devices, components and combination products. The specialist will assist in coordinating activities to support regulatory submissions for West’s products and maintain knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.

Essential Duties and Responsibilities:

• Develop and complete Human Factors and Usability Engineering Process activities with guidance for West products, including HF studies (formative, summative), and related documentation according to the latest global guidelines and applicable standards.
• Be a user and patient champion and voice in guiding the product requirements and user interface development. Understand and develop user’s needs, provide human factors technical expertise and guidance for concepts and design.   
• Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of usability/human factors content for submission to Health Authorities [DMFs, MAFs, 510(k)’s] in compliance with regulations, guidelines, and procedures.
• Clearly and effectively communicate team/project progress/status, decisions, deliverables timelines, as it relates to assigned projects and tasks. Provide Human Factors expertise and education as needed.
• Support customer regulatory requests related to Human Factors.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required.
• Other duties as assigned

Basic Qualifications: 

• Education: Minimum of BS or BSE in Human Factors, Ergonomics, Human systems engineering or other formal education in human factors related areas with bachelor’s degree in Science or related disciplines
• Experience: 3-5 years working in a human factors capacity within the medical device / pharmaceutical / healthcare sector specific related with medical device constituent of combination product, design control activities and human factors related activities
• Knowledge and experience with human factors related activities (such as HF studies protocols and reports (formative, summative)), related documentation according to FDA guidelines and applicable standards, such and task analysis, uFMEA, heuristic analysis is a plus

Preferred Knowledge, Skills and Abilities:

• Excellent interpersonal, communication and listening skills
• Be familiar with industry standards regarding human factors and usability (FDA, IEC 62366-1, AAMI HE75) in the medical device development process
• Able to understand and focus on empathy and users/patients experience
• Familiarity with FDA guidance documents and standards related to human factors, combination products, delivery system and design controls is a plus.
• Able to balance theoretical tools and practical experimentation to develop concepts and ideas
• International regulatory competency
• Advanced degree 
• Regulatory Affairs Certification (R.A.C)

Travel Requirements:

• Possible travel of 5-10%, as required and justified as business critical.

Physical & Mental Requirements:

• Sedentary work environment, exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.  If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.  Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.