B. Braun

Sr. Regulatory Affairs Specialist- Medical Devices + 510K filing req'd.

Job Locations US-PA-Allentown
Requisition ID
B. Braun Medical Inc
# of Openings
Position Type
Regular Full-Time
8am to 5pm
Allentown, PA


With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.


U.S. Facilities and Operations:


Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.


Position Summary:

To ensure marketing approval of B. Braun’s device products in the US and in foreign countries. To be a regulatory liaison with the FDA, Health Canada, other regulatory agencies as well as with internal cross functional departments and international RA colleagues for product development and changes to existing products. To perform job tasks independently and provide regulatory strategy.

 Responsibilities: Essential Duties

  • Prepare and submit Premarket Notifications [510(k)s], Investigational Device Exemptions (IDEs), and Premarket Approvals (PMAs).
  • Prepare and submit Canadian Device License Applications.
  • Prepare and submit Design Dossier and Technical Files for Europe.
  • Prepare and submit PMA supplements, PMA annual reports, and post market surveillance reports.
  • Review and approve product labeling and advertising.
  • Review change control documents for compliance with regulatory submissions requirements.
  • Coordinate and participate in routine FDA communications (including conference calls, written Correspondence and meetings).
  • Prepare regulatory assessments for new products and changes to existing products to determine the appropriate regulatory pathway to market.
  • Provide regulatory strategy, guidance and support as needed to Sales, Marketing, R&D, OEM, International, Engineering, Quality and Manufacturing.
  • Review and keep current with FDA regulatory requirements and trade publications.
  • Prepare written updates to management regarding status of regulatory tasks.

Expertise: Knowledge & Skills

  • Must possess knowledge of domestic (FDA) and foreign regulatory requirements for the manufacture and distribution of medical devices.
  • Must have working knowledge of the regulatory requirements for content and format of Premarket Notifications [510(k)s]. Knowledge of Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs) requirements is also desirable.
  • Must have working knowledge of Microsoft Windows software; Word, Excel, Access and PowerPoint.
  • Technical writing, computer literacy, review and analyze reports and data.
  • Must be able to communicate effectively (verbal and written) with governmental agencies and internal and external customers.
  • Must be able to meet deadlines, prioritize work, take the initiative to follow-up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently.





Expertise: Qualifications - Experience/Training/Education/Etc


  • Bachelor of Science degree (4-year degree) or equivalent work experience is required.
  • Specific regulatory experience and experience in the medical device/pharmaceutical industry is required.
  • Three to five years of experience in preparing and submitting Premarket Notifications [510(k)s].


  • Previous experience with Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs) is desired.
  • Additional Requirements:
  • International business travel is required.
  • Driver’s license is 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.


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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.


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:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 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. The noise level in the work environment is usually moderate.


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