BD Nogales Norte
Staff Regulatory Affairs Specialist (Hybrid)
BD Nogales Norte, San Diego, California, United States, 92189
Overview
Staff Regulatory Affairs Specialist (Hybrid) – BD Nogales Norte Join to apply for the Staff Regulatory Affairs Specialist (Hybrid) role at BD Nogales Norte. 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 processes 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 Workplace and policies
At BD, we prioritize on-site collaboration; minimum of 4 days in-office per week for most roles. Remote or field-based positions will have different arrangements indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where required by location, with accommodations considered pursuant to applicable law. Why Join Us
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth. We aim to help you reinvent the future of health and thrive in a culture that promotes accountability and improvement. Additional Information
Salary Range Information: 124,700.00 USD - 205,800.00 USD Annual. Primary location: USA CA - San Diego TC Bldg C&D. Employment type: Full-time. Job function: Legal. Industry: Manufacturing. BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, sex, national origin, or other legally-protected characteristics.
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Staff Regulatory Affairs Specialist (Hybrid) – BD Nogales Norte Join to apply for the Staff Regulatory Affairs Specialist (Hybrid) role at BD Nogales Norte. 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 processes 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 Workplace and policies
At BD, we prioritize on-site collaboration; minimum of 4 days in-office per week for most roles. Remote or field-based positions will have different arrangements indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where required by location, with accommodations considered pursuant to applicable law. Why Join Us
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth. We aim to help you reinvent the future of health and thrive in a culture that promotes accountability and improvement. Additional Information
Salary Range Information: 124,700.00 USD - 205,800.00 USD Annual. Primary location: USA CA - San Diego TC Bldg C&D. Employment type: Full-time. Job function: Legal. Industry: Manufacturing. BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, sex, national origin, or other legally-protected characteristics.
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