The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Combination Products, Medical Device, Pharmaceuticals, Quality/Risk Management
In this role, you will be responsible for applying human factors and usability engineering methods throughout the design and development processes for West’s Products, coordinating regulatory submissions for West’s products and processes 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 complete Human Factors and Usability Engineering Process activities with guidance for West products, including HF studies (formative, summative), and related documentation according to FDA guidelines and applicable standards.
Be the users 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 CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)’s], customer requests, etc. in compliance with regulations, guidelines and procedures.
Support project development teams and communicate regulatory progress, decisions, strategies, etc.
Support DVT strategy and related documents review.
Support pre-clinical studies and international clinical studies.
Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires and LOAs.
Develop specific objectives and manage work assignments, with minimal guidance, in an effort 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 and seek better alternatives and drive change.
Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
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
Education: Minimum of BS or BSE in Human Factors, Ergonomics, Industrial Engineering or extensive 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, 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.
Knowledge of medical device regulatory affairs and design control process, direct interactions with regulatory agencies and management of regulatory support systems is a plus.
Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
Able to balance theoretical tools and practical experimentation to develop concepts and ideas
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to comply with the company’s safety policy at all times
Able to comply with the company’s quality policy at all times.
Must be able to travel up to 10% of the time, with higher levels possible due to customer critical or business needs
Physical & Mental Requirements:
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.
Internal Number: 17585
About West Pharmaceutical Services, Inc.
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 $1.84B in 2019. 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 with Without Borders team member-led giving program.