About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Reporting to the Corporate Vice President of Regulatory Affairs, the Director of Regulatory Affairs for Medical Devices directs the activities of the Medical Device Regulatory Affairs staff.
Primary responsibilities include, (i.) the acquisition and maintenance of global (US, Canada, EU, Rest of World) medical device marketing authorizations (e.g., approvals, clearances, registrations, etc.), (ii.) serving as the chief company contact with global regulatory agencies, (iii.) interfacing with peers from internal functional departments, overseas B. Braun affiliates and development partners (e.g., Marketing, R&D, Regulatory Affairs, Medical Affairs, Operations, Quality, etc.) and (iv.) leading a team of regulatory professionals
Additional responsibilities include (.) sharing regulatory expertise with internal and external customers (ii.) developing/approving global regulatory strategies, and (iii.) continuous improvement.
The successful candidate will have broad knowledge in global Medical Device Regulatory Affairs, technical knowledge (e.g., active and non-active medical devices, software and cybersecurity, biocompatibility, engineering testing, etc.) and a proven ability to work within a certified quality system that includes manufacturing. They will also have strong written and verbal communication skills, executive presence, the ability to prioritize, and the ability to calculate risk.
Responsibilities: Essential Duties
Expertise: Knowledge & Skills
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
Expertise: Qualifications -Education/Experience/Training/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 20 pounds.
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.
While performing the duties of this job, the employee is expected to:
Lifting, Carrying, Pushing, Pulling and Reaching:
The work environment characteristics described here are representative of those an employee encounters while performing 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