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Global Hospital Care Materials Compliance Lead

Company: B. Braun Medical Inc.
Location: Allentown
Posted on: June 9, 2021

Job Description:

Overview

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.

Responsibilities

Position Summary:

The Hospital Care Material Compliance Lead will be responsible to ensure material compliance for the Global Hospital Care division product lines. This position will have the responsibility of working cross-functionally with many internal departments to assess impacted materials, products, and regulations. Additionally this role will lead material compliance related activities for Global Hospital Care Products with the guidance of the Materials Compliance Program Manager.

Responsibilities: Essential Duties

  • Lead for materials compliance responsible to ensure materials compliance at division level.
  • Maintains full understanding of HC products, parts, and suppliers to develop scope for each product category.
  • Serves as the SME of Program Regulations.
  • Consolidates, reviews, and reports material information from specific regulations impacting medical devices, their raw materials / components and suppliers. Liaises with engineering, as needed, to ensure validity of the information.
  • Works with Program Manager to address creation of letters to request material compliance information directly from the supplier or via an external service provider.
  • Monitors of supplier feedback and checking of data completeness at each site.
  • Coordinates the technical review of material compliance information with experts.
  • Works with Program Manager to provide structured data for the site.
  • Acts as a project manager to track and report on schedules, tasks, and deliverables for product compliance related activities for HC.
  • Responsible for internal/external customer requests at each site for the impacted regulations and analyze the data in Assent to provide back to customer.
  • Prepares submissions to regulators, customers, and other parties requesting compliance data, other material and product information (i.e. SCIP).
  • Creates and manages division level process/procedure (SOP).
  • Supports and drives continuous improvement of material compliance process.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

  • Requires full working knowledge of relevant business practices and procedures in professional field.
  • Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals.
  • May periodically assist in orienting, training, and/or reviewing the work of other peers.
  • Judgement is required in resolving all day-to-day problems.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers.
  • Frequent contact with external contractors/vendors.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

  • Bachelor's degree required.
  • 02-04 years related experience required.
  • Regular and predictable attendance
  • Ability to work non-standard schedule as needed

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.

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.

Other

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.

Physical Demands:

While performing the duties of this job, the employee is expected to:

  • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

  • Occasionally:Reaching upward and downward, Push/pull, Stand
  • Frequently:Sit
  • Constantly:N/A

Activities:

  • Occasionally:Finger feeling, Handling, Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
  • Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
  • Constantly:N/A

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:Moderate
  • Occasionally:Other
  • Frequently:N/A
  • Constantly:Office environment

Notices

Equal Opportunity Employer Veterans/Disabled

Keywords: B. Braun Medical Inc., Allentown , Global Hospital Care Materials Compliance Lead, Other , Allentown, Pennsylvania

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