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
Job Function - General:
Comprehend, analyze and interpret scientific and engineering data related to manufacturing, quality control testing, pre/non-clinical testing, clinical testing, etc.
Conduct regulatory research.
Support the product approval/clearance/registration/certification process.
Provide tactical and strategic guidance to cross-functional product development / project teams.
Draft well-written original NDAs, original ANDAs, controlled correspondence and other documentation [Pharma]; PMAs, De Novo Classification Requests, 510(k)s, Letters-to-File and other documentation [Device].
Support and manage documentation for international submissions.
Manage communications with the US FDA, Health Canada, notified bodies and other regulatory agencies/authorities.
Support product lifecycle activities (e.g. product launch, post-market surveillance, change control, modification, annual reports, labelling, obsolescence, etc.).
Support internal and external audits and inspections.
Keep current with laws, regulations, guidelines and standards related to drugs, biologics and medical devices, as
applicable.
It is the duty of every employee to take reasonable care for safety and health of himself/herself and others while
at work.
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.
Limit of Authorization/Authority:
Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.
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.
#ID#LI#MSL
Target Based Range
$108,700 - $118,700
Qualifications
Education and Professional Knowledge:
Bachelor's degree required or equivalent combination of education and experience.
Experience:
04-06 years related experience required.
Certification:
Applicable industry/professional certification preferred.
Knowledge and Skills Requirements:
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.
Supervision Given and Received:
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.
Problem Solving:
Judgement is required in resolving all day-to-day problems.
Contacts/Cooperation:
Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
Additional Requirement:
Occasional business travel required, Valid driver's license and passport, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed
Additional Information
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:
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:
Reaching upward and downward, Push/pull, Stand
Sit
Visual Acuity with or without corrective lenses
Climbing stairs/ladders, Handling, Kneeling/Crawling, Push/pull, Reaching upward and downward, Standing, Walking
Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting
Seeing - depth perception, color vision, field of vision/peripheral, Talking - ordinary, loud/quick
Environmental Conditions:
Occasionally:
Frequently:
Constantly:
Work Environment:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas) , Fumes, Gases, Dust
N/A N/A
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: Production/manufacturing environment, Warehouse environment, Lab environment
Frequently: N/A
Constantly: Office environment
What We Offer
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.
Notices
Equal Opportunity Employer Veterans/Disabled
