Technical Manager I-RA

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.

Job Function - General:

• Comprehend, analyze and interpret scientific/engineering data and product information in the context of regulatory intelligence and the current regulatory environment.
• Develop and implement complex regulatory strategies.
• Manage regulatory activities for product lines and/or programs.
• Serve as a subject matter expert (SME) for area(s) of responsibility.
• Provide strategic guidance to stakeholders; develop and implement complex regulatory strategies.
• 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].
• Interact with the US FDA, Health Canada, notified bodies and other regulatory agencies/authorities.
• Provide guidance to internal stakeholders on product lifecycle activities (e.g. launch, post-market surveillance, change control, modification, annual reports, labelling, obsolescence, etc.).
• Train and mentor junior colleagues.
• Keep current with science/engineering, the regulatory environment, products and industry trends. Actively involved with industry groups (eM, PDA, DIA, AdvaMed, MDMA, ASPEN, RAPS, etc.).

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 assigned by Management from time-to-time.

General:

It shall be the duty of every employee while at work to take a 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.

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Education and Professional Knowledge:

Bachelor's degree required, Master's degree preferred.

Experience:

08-10 years related experience required.

Certification:

Applicable industry/professional certification preferred.

Knowledge and Skills Requirements:

Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.

Supervision Given and Received:

Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.

Problem Solving:

Some degree of judgment required in resolving problems based on experience.

Contacts/Cooperation:

Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

Additional Requirement:

Frequent 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

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: Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas) , Fumes, Gases, Dust

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: Production/manufacturing environment, Warehouse environment, Lab environment

Frequently: N/A

Constantly: Other

Equal Opportunity Employer Veterans/Disabled