Mgr, Reg Affairs PA
Location:
Allentown , Pennsylvania
Posted:
September 08, 2017
Reference:
2017-9802
Overview: 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.

Responsibilities: Position Summary:

The purpose of this position is to ensure marketing approval of new and modified drug and device products in the US and foreign countries. As part of the Regulatory Affairs Group, the candidate will be responsible for global regulatory tasks including but not limited to regulatory submissions and registrations, regulatory liaison with regulatory agencies and project team participation to interact with internal functional departments. The candidate will provide strategic input and guidance to project teams and act in a supervisory capacity for regulatory staff.

Responsibilities: Essential Duties
  • Plan, develop, prepare, and review appropriate domestic and international regulatory submissions, such as NDAs, ANDAs, INDs, Premarket Notifications [510(k)s], Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs), etc.
  • Regulatory liaison with regulatory agencies and primary regulatory contact for assigned projects.
  • Supervise regulatory staff functions including development, training, performance reviews and setting objectives.
  • Provide input for regulatory requirements and regulatory strategy in interdepartmental meetings on product development to ensure timely submission and approval.
  • Review and make final determinations for regulatory assessments of proposed changes to existing products.
  • Read, review, interpret and keep current with regulations and publications regarding drug and device products.
  • Interact with B. Braun representatives of foreign countries and foreign health authorities regarding registration of products.
  • Budgeting and oversight of department budget.
  • Manage and prioritize development projects and day to day activities.
  • Coordinate/Manage meetings and Agency interactions.
Expertise: Knowledge & Skills
  • Excellent verbal and written communication skills
  • Skilled in planning, organizing, coordinating projects and working independently
  • Supervisory skills to oversee operations and develop career growth.
  • Computer literate - Microsoft Office.
  • Ability to prepare department reports and make management presentations
IN2017

#LI-GB1

Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc

Required:
  • BS/BA in scientific discipline.
  • Minimum five years experience in Regulatory Affairs.
  • Prior experience in direct interaction with regulatory agencies such as managing meetings and agency interactions.
  • Experience in the preparation of regulatory filings.
  • Experience in making regulatory assessments of proposed changes and how they will impact current submissions.
  • Able to analyze and develop strategies for regulatory submissions to ensure timely approval.
  • Both problem solving, decision making and negotiating skills are required to the extent that regulatory submissions impact B. Braun's ability to sell products and impact the company's financial standing.
  • Business travel requires valid driver's license, acceptable driving record and current passport.
Desired:
  • Advanced degree.
  • Regulatory Affairs certified.
  • Previous supervisory experience.
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.

Other: 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.

A little about us:
One of the world's leading healthcare suppliers.

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