We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

Job DescriptionUrology and Critical Care UCC is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.Responsibilities:Provide regulatory support through the product life cycle on product project teams e.g., developing regulatory strategies, timeline development, change control and preparing submission related documentsPrepare and audit 510ks, IDEs, PMA and/or international submissions as requiredProvide technical collaborate with FDA and international reviewers and respond to questionsProvide timely review and approval of product labeling and marketing claims for regulatory complianceProvide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluationsMinimum Requirements:BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalentRegulatory Affairs Certification RAC desiredKnowledge of the U.S. and European medical device regulations preferredMaintain confidentiality in dealing with regulatory and clinical documentationExcellent written and verbal communication s
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