Technical Dir, Reg Affairs

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:

Responsibilities: Essential Duties

• Supports Regulatory Affairs in the execution of departmental responsibilities in accordance with all applicable laws and the policies of the Organization.

• Establishes, monitors and ensures the successful completion of departmental objectives that further the overall objectives of the Organization.

• Serves as the final subject matter expert for area of responsibility; keeps abreast of the regulatory environment, engineering/science, industry trends and products.

• Provides strategic/tactical regulatory input/guidance to employees, project teams and other departments (e.g. Marketing, R&D, MSA, Quality, etc.).

• 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.

• 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].

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 breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.

• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.

• Judgement is required in resolving complex problems based on experience.

• Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.

Target Based Range

$136,856 - $177,912

Qualifications

Expertise: Qualifications

• Education/Experience/Training/Etc

Required:

• Bachelor's degree required.

• 10-15 years related experience, plus a minimum of 5 years management experience required.

• Applicable industry/professional certification preferred.

• Regular and predictable attendance

• 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

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.

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Additional Information

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, Visual Acuity with or without corrective lenses

• Frequently:Sit

• Constantly:N/A

Activities:

• Occasionally:Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Talking - ordinary, loud/quick

• Frequently:Finger feeling, Sitting

• Constantly:N/A

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, Lab environment, Other

• 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