Sep 14, 2019
Aesculap Inc. Associate Director, RA US-PA-Center Valley Job ID: 2019-14441 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aesculap Implant Systems Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: The Associate Director of Regulatory Affairs is responsible for Aesculap (AIC) and Aesculap Implant Systems (AIS) Regulatory Affairs. AIC/AIS Regulatory Affairs are responsible for obtaining and maintaining AIC and AIS product registrations, clearances and approvals through the US Food and Drug Administration. In this pursuit, they manage projects and proactively work with Marketing, Research and Development, Medical and Scientific Affairs, and other cross-functional groups through the product development process. AIC/AIS Regulatory Affairs also play a critical role in Product Life Cycle Management, from concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the US Food and Drug Administration, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector. Responsibilities: Essential Duties Principal Duties & Authorities: Assists the Vice President of Regulatory Affairs in executing RA responsibilities in accordance with all applicable laws and corporate policies. Assists in the development of RA goals/objectives (MBOs). Responsible for meeting/exceeding MBOs. Develops/implements processes, procedures and metrics to effectively manage RA activities. Responsible for weekly, quarterly and annual reports for RA. Coordinates company-wide announcements related to RA. Works with legal counsel, consultants and other experts, as required. Interacts with US FDA, industry groups ( g. AdvaMed, OSMA), corporate partners and vendors. Assists Regulatory staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances. Reviews and approves submissions to the US FDA. Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders. Assists in the development and review of product labeling, packaging, advertising and promotional information. Organizes RA department meetings. Addresses departmental and other Regulatory issues and problems. Recommends appropriate courses of action to Executive Management, as necessary. Manages facility registrations. Assists Quality Assurance with FDA inspections and internal/ external audits. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties may be assigned Secondary or peripheral job functions: Requires excellent written, oral and interpersonal communication skills. Computer skills in Windows, MS Word, Excel and Power Point. Must be able to travel by automobile, train and airplane, and work occasional weekends. Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others. Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes. Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices. Supervisory Responsibilities: Manages a department of Regulatory Affairs Program/Project Managers, Senior Specialists and Specialists. Encourages high performance to meet corporate goals. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning, managing and monitoring work; appraising, rewarding and disciplining employees; and addressing complaints and resolving problems. Expertise: Knowledge & Skills Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Qualifications Expertise: Qualifications - Experience/Training/Education/Etc Required: Bachelor’s degree in Engineering or Technical/Life Science discipline. Master’s degree preferred. Minimum of 8-10 years of Regulatory Affairs experience in an FDA-regulated industry. Medical device industry experience highly preferred. Minimum of 5 years of managerial experience required. RA/QA/MSA employees highly preferred. Substantial experience directly interacting with the US FDA ( g. meetings, negotiations). Practical knowledge of product development, product life cycle management, design controls, medical device registration/clearance/approval, QSR and GMP desired. Practical experience with testing ( g. bench testing, biocompatibility testing, etc. ), spine and/or orthopedics desired. Regulatory Affairs Certification a plus. Desired N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
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Center Valley, Upper Saucon Township, PA, USA