Regulatory Affairs Specialist
Company: B. Braun Medical
Posted on: May 16, 2022
B. Braun Medical, Inc.
Regulatory Affairs Specialist
Job ID: 2022-20427
# of Openings: 1
Corp at Allentown Auxiliary
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 .
To plan and prepare registration documents for marketing approval
of B. Braun's drug products in the US and Canada with minimal
supervision. To be a regulatory liaison for new product development
and make regulatory assessments of proposed changes to existing
products for impact to regulatory documentation. To independently
provide strategic input and guidance to project teams. A person in
this position will have excellent analytical abilities, strong
communication skills, and effective attention to detail with at
least a 4 year degree in a scientific or technical field.
Responsibilities: Essential Duties
Plans and prepares registration documents for marketing approval of
drug and device products in the US and in foreign countries.
Serves as a regulatory liaison for new product development and make
regulatory assessments of proposed changes to existing products for
impact to regulatory documentation.
Provides strategic input and guidance to project teams in
conjunction with supervisor.
Plans and prepares dossiers for registration of drug and device
Independently reviews and analyzes proposed modifications to drug
and device products for regulatory impact.
Independently reads, reviews, interprets and keeps current with
regulations and publications regarding drug and device products and
communicate within the department.
May oversee and direct the work of other Regulatory Affairs
The job function listed is not exhaustive and shall also include
any responsibilities as assigned by the Supervisor from time to
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
Work under minimal supervision. Relies on experience and judgement
to plan and accomplish assigned goals. May periodically assist in
orienting, training, assigning and checking the work of lower level
employees. Referring only complex problems and issues
Judgement is required in resolving complex problems based on
Contacts are primarily with department supervisors, leads,
subordinates, and peers. Occasional contact with external
Expertise: Qualifications -Education/Experience/Training/Etc
Bachelor's degree required.
02-04 years related experience required.
Applicable industry/professional certification preferred.
Regular and predictable attendance
Occasional business travel required
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
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
Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward
and downward, Standing, Walking
Frequently:Finger feeling, Hearing - ordinary, fine distinction,
loud (hearing protection required), Seeing - depth perception,
color vision, field of vision/peripheral, Sitting , Talking -
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
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
Through its Sharing Expertise - initiative, B. Braun promotes best
practices for continuous improvement of healthcare products and
Equal Opportunity Employer Veterans/Disabled
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Keywords: B. Braun Medical, Allentown , Regulatory Affairs Specialist, Other , Allentown, Pennsylvania
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