Postmarket Surveillance Spec

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 61,000 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.

Position Summary:

We are looking for a seasoned clinical professional with risk management experience. A candidate with a nursing or pharmacist background is preferred. The Specialist, Postmarket Surveillance is responsible for assisting the Manager, Postmarket Surveillance in oversight and administration of the B. Braun Post-Market Surveillance System. They monitor and analyze all aspects of post-market data to identify potential health and safety risks, opportunities for product quality improvement, and ensure that all applicable regulatory and industry standards for complaint management and regulatory reporting are met. They work collaboratively across all departments and manufacturing sites to ensure that B. Braun maintains a position as a premiere provider of quality healthcare products to the markets we serve. A strong clinical or risk management background is desired. The position has the option to be primarily remote with the ability to report into the office when required.

Responsibilities: Essential Duties

• Assists the product quality excellence leadership in oversight and administration of the B. Braun post Market Surveillance System.
• Monitors and analyzes all aspects of post market data to identify potential health and safety risks, opportunities for product quality improvement and ensures that all applicable regulatory and industry standards for complaint management and regulatory reporting are met.
• Works collaboratively across all departments and manufacturing sites to ensure that B. Braun maintains a position as a premiere provider of quality healthcare products to the markets served.

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.

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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required

• 04-06 years related experience required.

• Applicable industry/professional certification preferred.

• Regular and predictable attendance

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.

Physical Requirement and Work Environment:

Attendance Requirement Regular and predictable attendance
Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is expected to:

Moderate work - Exerting up to 40 lbs of force occasionally, and/or up to 20 pounds of force frequently, and/or 10 lbs force constantly to move objects

Lifting, Carrying, Pushing, Pulling and Reaching:

Occasionally: Reaching upward and downward, Push/pull

Frequently: Stand, Sit

Constantly: Visual Acuity with or without corrective lenses

Activities:

Occasionally: Climbing stairs/ladders

Frequently: Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Standing, Talking - ordinary, loud/quick

Constantly: Seeing - depth perception, color vision, field of vision/peripheral

Environmental Conditions:

Occasionally: N/A

Frequently: N/A

Constantly: N/A

Work Environment:

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.

Noise Intensity: Low

Occasionally: Production/manufacturing environment

Frequently: N/A

Constantly: Office environment

Equal Opportunity Employer Veterans/Disabled

PI256321350