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.
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
- Acts as a project manager to track and report on schedules,
tasks, and deliverables for product compliance related activities
- 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
- Supports and drives continuous improvement of material
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
- Contacts are primarily with department supervisors, leads,
subordinates, and peers.
- Frequent contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
- 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
Through its "Sharing Expertise" initiative, B. Braun promotes
best practices for continuous improvement of healthcare products
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
- 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,
- 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
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
- Noise Intensity:Moderate
- Constantly:Office environment
Equal Opportunity Employer Veterans/Disabled