The employee is occasionally required to stand and walk. The employee frequently is required to use hands to handle or feel and reach with hands and arms. While performing the duties of this job, the employee is regularly required to sit and talk or hear. Applicable industry/professional certification preferred.02-04 years related experience required.The range provided is a reasonable estimate.Įxpertise: Qualifications -Education/Experience/Training/Etc Compensation decisions are dependent on the facts and circumstances of each case. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. 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. Occasional contact with external contractors/vendors. Contacts are primarily with department supervisors, leads, subordinates, and peers.Judgement is required in resolving complex problems based on experience.Referring only complex problems and issues May periodically assist in orienting, training, assigning and checking the work of lower level employees. Relies on experience and judgement to plan and accomplish assigned goals. Uses standard theories, principles and concepts and integrates them to propose a course of action. Requires full working knowledge of relevant business practices and procedures in professional field.The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. May oversee and direct the work of other Regulatory Affairs professionals.Independently reads, reviews, interprets and keeps current with regulations and publications regarding drug and device products and communicate within the department.Independently reviews and analyzes proposed modifications to drug and device products for regulatory impact.Plans and prepares dossiers for registration of drug and device products.Provides strategic input and guidance to project teams in conjunction with supervisor.Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.Plans and prepares registration documents for marketing approval of drug and device products in the US and in foreign countries.This position will work closely with other departments to maintain compliance with regulatory requirements, support regulatory strategy development, and prepare documents for submission to regulatory authorities, as required. Position Summary: The Regulatory Affairs Specialist will provide regulatory support and strategy development for pharmaceutical products from early feasibility through marketing authorization. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. Guided by its Sharing Expertise ® philosophy, B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Braun Interventional Systems, Aesculap ® and CAPS ®. Braun Group of Companies in the U.S., which includes B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry.
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