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.
To plan and prepare registration documents for marketing approval of B. Braun’s drug and device products in the US and in foreign countries under minimal supervision. To be a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
Responsibilities: Essential Duties
Prepares routine regulatory applications such as annual reports, adverse event reporting, wholesale distribution licensing, establishment registrations, drug/device listings, CPPs, and CFGs
Prepares dossiers for registration of drug and device products.
Provides input for development of regulatory strategies. Reviews labeling and regulatory documents for accuracy and compliance with regulations.
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 full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
Judgement is required in resolving complex problems based on experience.
Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
Research and analyze requests received from Research and Development, Marketing and International Sales Division.
Plan and prepare dossiers for registration of drug and device products such as IND/NDA/ANDA and 510(k)/IDE/PMAS.
Participate and provide regulatory input for product development teams.
Review, analyze and prepare written assessment for proposed modifications to drug and device products for regulatory impact.
Read, review, interpret and keep current with regulations, recognized standards and publications regarding drug and device products.
Interact with B. Braun representatives of foreign countries regarding registration of drug and device products.
Interact with regulatory agencies concerning regulatory filings with minimal supervision.
Provide regulatory guidance to interdepartmental members concerning B. Braun filings
Review regulatory documents for submissions to regulatory agencies.
Review labeling for accuracy and compliance with regulations.
Other duties as assigned.
Experience in preparation of regulatory filings in pharma or medical device settings.
Knowledge of ICH, ISO, CTD/eCTD/STED and international regulations.
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.
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.