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.
Direct the activities of the Pharmaceutical Regulatory Affairs staff jointly with the Device RA Management staff related to obtaining product approval and maintaining global product marketing rights. Act as direct liaison and chief company contact with regulatory agencies, as well as with other internal functional departments for new product development and product life cycle strategy. Oversees existing products and obtains new marketing approval for new/modified drug and device applications globally. Act in a supervisory capacity for regulatory functions.
Responsibilities: Essential Duties
Assists the SVP Medical Scientific Affairs & Chief Medical Officer and Corporate VP Regulatory Affairs in carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.
Resident regulatory affairs authority for and primary regulatory contact for assigned product lines or projects.
Provides input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval. Determine regulatory filing strategies and submission types.
Reviews drug and device applications for market approval/clearance.
Reviews and makes final determinations for regulatory assessments of proposed changes to existing products.
Obtains regulatory verification and confirm strategy with outside legal counsel.
Reads, reviews, interprets and keeps current with regulations and publications regarding drug and device products.
Interacts with representatives of domestic and international partner companies/ subsidiaries and international regulatory authorities to discuss regulatory issues and submission requirements.
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.
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.