BD Nogales Norte
Job Title and Location
Director Regulatory Affairs at BD Nogales Norte Overview
The Director Regulatory Affairs (RA) position reports directly to the BD Interventional Segments Surgery VP Regulatory Affairs. This role is responsible for the development and leadership of the regulatory affairs function in the Surgical Solutions platform. It includes developing and communicating RA strategies for the Surgery Business Units innovation pipeline in areas such as hemostats, sealants, and infection prevention products. The Director will collaborate with Surgery RA Platform leads, the Surgery Strategic Development and Innovation teams, and across BDs Interventional Segment RA groups to aid in RA Strategy development. Through recruiting, hiring, supervision, and development of regulatory affairs personnel in support of key product development programs and business objectives, the Director ensures compliance with applicable regulations for all pre-market and post-market product support activities. Responsibilities
Recruit, manage, develop and mentor regulatory professionals. Utilize technical regulatory skills to propose strategies on complex issues. Provide regulatory input to product lifecycle planning. Work with regulatory associates to determine submission and approval requirements. Assist in regulatory due diligence and acquisition transfer activities. Provide strategic input and technical guidance on regulatory requirements to development teams. Manage and execute pre-approval compliance activities. Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Negotiate and interact with regulatory authorities during development and review processes to secure submission approvals and build positive relationships with reviewers. Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor and submit applicable reports and responses to regulatory authorities. Maintain annual licenses, registrations, listings and patent information. Ensure compliance with post-marketing approval requirements. Review and approve labeling to ensure regulatory compliance. Review and approve advertising and promotional items for regulatory compliance. Assess external communications relative to regulations. Review publicly disseminated information to minimize regulatory exposure, review product claims, and preserve confidentiality of applicable product information. Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations. Provide regulatory input for inspections and audits and support follow-up actions. Develop, implement and manage SOPs and systems to track and manage product-associated events. Submit/review change controls to determine the level of change and submission requirements. Provide regulatory input for product recalls and recall communications. Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance. Communicate regulatory agency/industry positions to internal stakeholders. Advise internal stakeholders on regulatory issues and requirements. Conduct technical meetings with regulatory advisory committees and government agencies. Accompany inspection teams as required. Support and lead assigned improvement activities. Notify, consult or brief legal counsel when appropriate. Function as authorized delegate for the function head when required. Prepare and lead professional associations and standards organizations involvement as appropriate. Qualifications
Bachelors degree or advanced degree in a technical area (e.g., biology, chemistry, engineering or medical-related field) with a minimum of ten years of experience. Advanced degree preferred. Preferred minimum of 10-15 years of experience in the medical device industry, with at least ten years in a regulatory role. Comprehensive knowledge of U.S., European, and international regulations and standards for medical devices. Strong organizational, planning, and program management skills, with action orientation and drive for results. Experience in continuous improvement projects, project management, product development processes, and design control. Excellent project management skills with the ability to prioritize and manage multiple projects. Ability to adapt to change and communicate risk and uncertainty effectively. Prior management experience and ability to exercise independent judgment within policy guidelines. Ability to work on complex projects with ambiguity and rapid change; self-starter and highly motivated. Strong written and verbal communication skills, including cross-cultural communication and negotiation with Regulators. Ability to interpret medical device testing methods and statistics, as applicable. Knowledge of current and future regulatory policies, practices, trends, technology and information affecting the business. Experience with Clinical Trial applications (US IDE). For certain roles at BD, employment is contingent upon proof of full COVID-19 vaccination. In some locations, testing may be available or required. BDs Workplace Accommodations Policy will be followed for requests for accommodation according to applicable law. At BD, we prioritize on-site collaboration because it fosters creativity, innovation, and effective problem-solving. We require a minimum of 4 days in-office presence per week to maintain our culture of excellence, while recognizing the need for flexibility and work-life balance. Why Join Us?
A career at BD values your opinions and contributions and encourages you to bring your authentic self to work. You will work with inspirational leaders and colleagues who are committed to fostering an inclusive, growth-centered and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a lasting impact. Equal Opportunity Statement
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr
Director Regulatory Affairs at BD Nogales Norte Overview
The Director Regulatory Affairs (RA) position reports directly to the BD Interventional Segments Surgery VP Regulatory Affairs. This role is responsible for the development and leadership of the regulatory affairs function in the Surgical Solutions platform. It includes developing and communicating RA strategies for the Surgery Business Units innovation pipeline in areas such as hemostats, sealants, and infection prevention products. The Director will collaborate with Surgery RA Platform leads, the Surgery Strategic Development and Innovation teams, and across BDs Interventional Segment RA groups to aid in RA Strategy development. Through recruiting, hiring, supervision, and development of regulatory affairs personnel in support of key product development programs and business objectives, the Director ensures compliance with applicable regulations for all pre-market and post-market product support activities. Responsibilities
Recruit, manage, develop and mentor regulatory professionals. Utilize technical regulatory skills to propose strategies on complex issues. Provide regulatory input to product lifecycle planning. Work with regulatory associates to determine submission and approval requirements. Assist in regulatory due diligence and acquisition transfer activities. Provide strategic input and technical guidance on regulatory requirements to development teams. Manage and execute pre-approval compliance activities. Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Negotiate and interact with regulatory authorities during development and review processes to secure submission approvals and build positive relationships with reviewers. Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor and submit applicable reports and responses to regulatory authorities. Maintain annual licenses, registrations, listings and patent information. Ensure compliance with post-marketing approval requirements. Review and approve labeling to ensure regulatory compliance. Review and approve advertising and promotional items for regulatory compliance. Assess external communications relative to regulations. Review publicly disseminated information to minimize regulatory exposure, review product claims, and preserve confidentiality of applicable product information. Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations. Provide regulatory input for inspections and audits and support follow-up actions. Develop, implement and manage SOPs and systems to track and manage product-associated events. Submit/review change controls to determine the level of change and submission requirements. Provide regulatory input for product recalls and recall communications. Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance. Communicate regulatory agency/industry positions to internal stakeholders. Advise internal stakeholders on regulatory issues and requirements. Conduct technical meetings with regulatory advisory committees and government agencies. Accompany inspection teams as required. Support and lead assigned improvement activities. Notify, consult or brief legal counsel when appropriate. Function as authorized delegate for the function head when required. Prepare and lead professional associations and standards organizations involvement as appropriate. Qualifications
Bachelors degree or advanced degree in a technical area (e.g., biology, chemistry, engineering or medical-related field) with a minimum of ten years of experience. Advanced degree preferred. Preferred minimum of 10-15 years of experience in the medical device industry, with at least ten years in a regulatory role. Comprehensive knowledge of U.S., European, and international regulations and standards for medical devices. Strong organizational, planning, and program management skills, with action orientation and drive for results. Experience in continuous improvement projects, project management, product development processes, and design control. Excellent project management skills with the ability to prioritize and manage multiple projects. Ability to adapt to change and communicate risk and uncertainty effectively. Prior management experience and ability to exercise independent judgment within policy guidelines. Ability to work on complex projects with ambiguity and rapid change; self-starter and highly motivated. Strong written and verbal communication skills, including cross-cultural communication and negotiation with Regulators. Ability to interpret medical device testing methods and statistics, as applicable. Knowledge of current and future regulatory policies, practices, trends, technology and information affecting the business. Experience with Clinical Trial applications (US IDE). For certain roles at BD, employment is contingent upon proof of full COVID-19 vaccination. In some locations, testing may be available or required. BDs Workplace Accommodations Policy will be followed for requests for accommodation according to applicable law. At BD, we prioritize on-site collaboration because it fosters creativity, innovation, and effective problem-solving. We require a minimum of 4 days in-office presence per week to maintain our culture of excellence, while recognizing the need for flexibility and work-life balance. Why Join Us?
A career at BD values your opinions and contributions and encourages you to bring your authentic self to work. You will work with inspirational leaders and colleagues who are committed to fostering an inclusive, growth-centered and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a lasting impact. Equal Opportunity Statement
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr