BD (Tissuemed Ltd)
Staff Regulatory Affairs Specialist (Hybrid)
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Staff Regulatory Affairs Specialist (Hybrid)
3 weeks ago Be among the first 25 applicants BD 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. This position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is responsible for developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies. Responsibilities
Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Represents MMS-Infusion for regulatory projects and leads the efforts for successful implementation. Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders. Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Prepare global strategies for changes to commercialized products. Work cross-functionally and lead cross-functional teams to implement global updates. Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about potential impact. Identify ways to improve the efficiency of current work process and execute them. Performs other duties and assignments as required. Qualifications
Education Bachelor’s degree in biology, engineering, or other science related discipline Advanced degree (e.g. MS, PhD) preferred Certifications RAPS RAC RCC certifications preferred Experience Minimum of 5 years of directly related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field Experience in Regulatory and Quality Information Management systems such as SAP, RIM, Veeva, Sharepoint or related systems Working experience on creating dashboards and data analysis using tools like Power BI. Knowledge and Skills Working knowledge Regulatory Systems implementation Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information Digital literacy MS Word, Excel, PowerPoint, Teams, Power BI Effectively communicate information to peers and all levels of management. Ability to translate regulations and guidelines into terms that other functions can understand and apply Ability to define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists We prioritize on-site collaboration, require a minimum of 4 days of in-office presence per week, and have COVID-19 vaccination requirements and accommodations in line with BD’s policies. BD is an Equal Opportunity Employer.
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3 weeks ago Be among the first 25 applicants BD 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. This position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is responsible for developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies. Responsibilities
Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Represents MMS-Infusion for regulatory projects and leads the efforts for successful implementation. Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders. Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Prepare global strategies for changes to commercialized products. Work cross-functionally and lead cross-functional teams to implement global updates. Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about potential impact. Identify ways to improve the efficiency of current work process and execute them. Performs other duties and assignments as required. Qualifications
Education Bachelor’s degree in biology, engineering, or other science related discipline Advanced degree (e.g. MS, PhD) preferred Certifications RAPS RAC RCC certifications preferred Experience Minimum of 5 years of directly related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field Experience in Regulatory and Quality Information Management systems such as SAP, RIM, Veeva, Sharepoint or related systems Working experience on creating dashboards and data analysis using tools like Power BI. Knowledge and Skills Working knowledge Regulatory Systems implementation Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information Digital literacy MS Word, Excel, PowerPoint, Teams, Power BI Effectively communicate information to peers and all levels of management. Ability to translate regulations and guidelines into terms that other functions can understand and apply Ability to define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists We prioritize on-site collaboration, require a minimum of 4 days of in-office presence per week, and have COVID-19 vaccination requirements and accommodations in line with BD’s policies. BD is an Equal Opportunity Employer.
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