B. Braun

Director, Regulatory Affairs

Job Locations US-PA-Center Valley
Requisition ID
2023-23555
Company
B. Braun Medical Inc
# of Openings
1
Category
Regulatory
Position Type
Hybrid Full Time
Shift
Full Time ; Exempt
Site
Corporate

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 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.

Responsibilities

Position Summary:

Reporting to the Corporate Vice President of Regulatory Affairs, the Director of Regulatory Affairs for Medical Devices directs the activities of the Medical Device Regulatory Affairs staff.   

 

Primary responsibilities include, (i.) the acquisition and maintenance of global (US, Canada, EU, Rest of World) medical device marketing authorizations (e.g., approvals, clearances, registrations, etc.), (ii.) serving as the chief company contact with global regulatory agencies, (iii.) interfacing with peers from internal functional departments, overseas B. Braun affiliates and development partners (e.g., Marketing, R&D, Regulatory Affairs, Medical Affairs, Operations, Quality, etc.) and (iv.) leading a team of regulatory professionals 

 

Additional responsibilities include (i.) sharing regulatory expertise with internal and external customers (ii.) developing/approving global regulatory strategies, and (iii.) continuous improvement.   

 

The successful candidate will have broad knowledge in global Medical Device Regulatory Affairs, technical knowledge (e.g., active and non-active medical devices, software and cybersecurity, biocompatibility, engineering testing, etc.) and a proven ability to work within a certified quality system that includes manufacturingThey will also have strong written and verbal communication skills, executive presence, the ability to prioritize, and the ability to calculate risk. 

 

 

Responsibilities: Essential Duties

 

  • Supports the Corporate Vice President of Regulatory Affairs in the execution of departmental responsibilities in accordance with all applicable laws and the policies of the Organization. 
  • Responsible for interviewing, hiring, training, developing, assessing, rewarding/disciplining and motivating employees; addressing employee complaints and resolving problems; and planning, assigning, directing and ensuring high quality work product; providing technical and regulatory guidance. 
  • Establishes, monitors and ensures the successful completion of departmental objectives that further the overall objectives of the Organization. 
  • Drives the continuous improvement of the quality and timeliness/efficiency of work product, services and departmental processes using data-driven approaches (e.g. KPIs and metrics). 
  • 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.). 
  • Works with legal counselInteracts with domestic/international partners and regulatory agencies. 
  • Train and mentor junior colleagues. 
  • Keep current with science/engineering, the regulatory environment, products and industry trends.   
  • Represent the company with industry groups (e.g. AdvaMed, MDMA, 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 as assigned by the Supervisor from time to time.
 

 

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.
  • Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
  • 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.

 

 

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.

Target Based Range

$132,870 - $175000

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.

 

 

#ID

#LI

#DL

 

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, Walking
  • Frequently:Finger feeling, Sitting
  • Constantly:N/A

Environmental Conditions:

  • Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
  • 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:Low
  • 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

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.