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.
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:
Secondary or peripheral job functions:
Expertise: Knowledge & Skills
Expertise: Qualifications - Experience/Training/Education/Etc
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.
B. 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.
Responsibilities: Other Duties
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Equal Opportunity Employer Veterans/Disabled