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Location

Exton, PA | United States

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Job description

IntePros is currently looking for a Principal Regulatory Affairs, Human Factors to join one of our premier medical device clients in Exton, PA. The Principal Regulatory Affairs, Human Factors will be responsible for applying human factors and usability engineering methods throughout the design and development processes for client's Products including devices, components, and combination products. The Principal will lead activities to support regulatory submissions for client's products and maintain knowledge of current US and international regulations/guidelines/policies applicable to client's products and services.

Principal Regulatory Affairs, Human Factors Responsibilities:

• Develop and execute Human Factors and Usability Engineering program activities for client products, including usability risk analysis, HF studies (moderation, data collection, root cause analyses), postmarket risk control enhancement, and related documentation according to the latest global guidelines and applicable standards.
• Be a user and patient champion in guiding proactive product requirements and user interface development to reduce use risk and improve ease of use. Understand and develop users' needs, provide human factors technical expertise and guidance for concepts and design.
• Lead regulatory assignments 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.
• Partner with customers and HF vendors to support HF research needs and regulatory submissions.
• Educate internal and cross-functional teams about HFE principles, regulatory requirements, and importance of proactive HF activities.
• 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

Principal Regulatory Affairs, Human Factors Basic Qualifications:

• Education: Bachelor's, Master's, or PhD in Human Factors, Ergonomics, Human Systems Engineering or other formal education in human factors related areas with bachelor's degree in science or related discipline
• Experience: Bachelor's with 4-6 years; Master's/PhD with 3-4 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
• Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
• Experience with risk analysis as specifically applied to human factors (e.g., AFMEA, uFMEA, URRA)

Principal Regulatory Affairs, Human Factors Preferred Knowledge, Skills and Abilities:

• Excellent interpersonal, communication and listening skills
• Able to understand and focus on empathy and user/patient experience
• 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 25% domestically and internationally, as required and justified as business critical.

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

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