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 Description***Role is onsite in Covington, Georgia***Job ResponsibilitiesDevelop and implement comprehensive regulatory strategies for new product development, productlife cycle management, and post-market surveillance activities.Prepare, review, and submit regulatory documents, including 510ks, Dossiers, Technical Files, and other international submissions to global health authorities.Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections.Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process.Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement.Participate in internal and external audits, providing regulatory expertise and support.Assess the regulatory impact of product changes, manufacturing changes, and quality system changes.Collaborate effectively with R&D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives.Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio.Job QualificationsBachelor's degree in a scientific or technical discipline e.g., Biomedical Engineering, Chemistry, Biology required. Advanced degree MS, PhD preferred.Minimum of 8-10 year
