Title:  Sr. 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:

Responsible for leading human factors and usability engineering methods throughout the design and development processes for West’s Products, coordinating human factor activities for West’s products and processes to support West customers regulatory activities and maintain knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.

Essential Duties and Responsibilities:

• Develop and lead Human Factors and Usability Engineering Process activities with guidance for West Products, including Human Factor Studies (formative/summative), and related documentation according to FDA guidelines and applicable standards.
• Be the users and patient champion and voice in determining the product requirements and user interface development. Understand and develop user’s needs, provide human factors technical expertise and guidance for concepts and design.
• Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards. As well as evaluate impact for the end user in regard to Human Factors. 
• Guide research initiatives relating to medical device and combination product development.
• Work with RA team to build Human Factor strategies for combination product development platforms.
• Participate on project development teams and provide human factor guidance and communicate progress, decisions, strategies, to cross functional teams.
• Review technical and design specifications, project documentation, validation plans, etc. providing guidance and direction where applicable.
• Provide customers with West product related information and data as required for regulatory submissions to European and Rest of World agencies.
• Create documentation in response to customer human factor requests which includes technical packages, presentations, etc.
• Train, mentor and/or guide the activities of RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.
• Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West’s products and business.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• 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, seek better alternatives, and drive change.
• Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.

Basic Qualifications: 

• Education:  Bachelor, Master’s degree, or PhD in related discipline
• Experience: Bachelors with 3-5 years; or Master’s degree/PhD with 1-3 years Medical Device / Combination Product regulatory and human factor experience.

Preferred Knowledge, Skills and Abilities:

• Experience with industry standards regarding human factors and usability (FDA, IEC 62366-1, HE75) in the medical device development process
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
• Knowledge of medical device regulatory affairs and design control process, direct interactions with regulatory agencies and management of regulatory support systems is a plus
• Strong working knowledge of medical device and combination product regulations
• Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
• Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.

Travel Requirements:

• Must be able to travel up to 5-10% of the time

Physical and Mental Requirements:

• Sedentary environment; ability to work in an office; may need to stand or sit for extended periods of time
• Ability to comprehend principles of math, science, engineering, and medical device use
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents
• Ability to review, collate, describe, and summarize scientific and technical data
• Ability to organize complex information and combine pieces of information to form general rules or conclusions
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures
• Ability to build strong relationships both internally and externally
• Ability to work in a fast-paced environment
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
• Ability to verbally communicate ideas and issues effectively to other team members and management
• Ability to write and record data and information as required by procedures
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company)

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.