BD Nogales Norte
Staff Regulatory Affairs Specialist - BD Excellence
BD Nogales Norte, Vernon Hills, Illinois, United States, 60061
Staff Regulatory Affairs Specialist - BD Excellence
Join to apply for the
Staff Regulatory Affairs Specialist - BD Excellence
role at
BD Nogales Norte . The Staff Regulatory Affairs Specialist BD Excellence position reports directly to the BD Interventional Segments Surgery VP Regulatory Affairs with a dotted line to the Associate Director of BD Excellence for Surgery. This position is responsible for managing, assessing, and executing regulatory activities for existing drug and medical device products to create savings for the Surgery business. The role works closely with regulatory affairs product owners and the cross-functional team to assess changes and author submissions to implement change globally. It is responsible for developing and communicating RA strategies related to BD Excellence for the Surgery Business Units products, including Advanced Repair & Reconstruction and Surgical Solutions product portfolios. Through collaboration with key stakeholders, the Staff Regulatory Affairs Specialist BD Excellence will negotiate with regulators and help ensure cost savings for the Surgery business. Job Description BD is one of the largest global medical technology companies in the world. We are dedicated to advancing health and creating transformative solutions. The Staff Regulatory Affairs Specialist BD Excellence is a strategic thought partner to the Business Unit, supporting productivity and collaborating with cross-functional partners to provide regulatory expertise. This role develops regulatory strategies that lead products through the FDA clearance/approval process, as well as other global regulatory agencies. Responsibilities Include Write drug and medical device regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), PMA supplements, 510(k)s, and Regulatory authority responses. Propose strategies on complex regulatory issues using technical regulatory skills. Determine deliverables for regulatory submissions and communicate with appropriate functional representatives to ensure timely and accurate submissions per business objectives. Collaborate with R&D, Manufacturing, Quality, and other areas to review regulatory strategy and impact of product changes. Support OUS RA team members to maintain effective collaboration and synchronize domestic and international submissions. Work with regulatory product owners to determine submission and approval requirements. Assess the acceptability of testing and documentation for submission filing. Negotiate and interact with regulatory authorities during the review process to secure submission approval. Build positive relationships with regulatory reviewers. Monitor changes in regulations and update internal partners on submission strategies. Submit and respond to applicable regulatory reports and inquiries. Submit/review change controls to determine the level of change and submission requirements. Strategize with and advise internal partners on regulatory issues and requirements. Conduct technical meetings with regulatory advisory committees and government agencies. Support and lead assigned improvement/productivity activities.
Skills/Knowledge
Knowledge of United States, European, and international regulations and standards covering medical devices. Demonstrated organizational, planning, and program management skills with action orientation and results focus. Experience in continuous improvement projects, project management, product development processes, and design control. Excellent project management abilities, including prioritization and multitasking. Ability to adapt to change and communicate risk and uncertainty effectively. Excellent written and verbal communication, including cross-cultural communication and negotiation with Regulators. Ability to interpret medical device and drug testing methods and statistics, as applicable. Knowledge of current and future policies, practices, trends, technology, and information affecting the business.
Required Qualifications
Bachelors degree in a technical field such as biology, chemistry, engineering or medical-related area.
Preferred Qualifications
5 years of experience in the medical device industry, with at least 3 years in a regulatory role. Advanced degree (Masters or PhD).
On-site collaboration is prioritized in this organization to foster creativity and problem-solving. For most roles, a minimum of 4 days in-office presence per week is expected to maintain our culture of excellence. Remote or field-based positions will have different workplace arrangements indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where permitted by law. Requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions, encourages you to be your authentic self, and supports learning and growth. BD aims to help you reinvent the future of health and find satisfaction in contributing to meaningful work. To learn more about BD, visit the BD Careers site. BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information $113,400.00 - $186,900.00 USD Annual Location USA RI - Warwick; USA IL - Vernon Hills Employment type Full-time Job function Legal Industry Manufacturing Additional job listings and referral prompts have been omitted for clarity and relevance. #J-18808-Ljbffr
Join to apply for the
Staff Regulatory Affairs Specialist - BD Excellence
role at
BD Nogales Norte . The Staff Regulatory Affairs Specialist BD Excellence position reports directly to the BD Interventional Segments Surgery VP Regulatory Affairs with a dotted line to the Associate Director of BD Excellence for Surgery. This position is responsible for managing, assessing, and executing regulatory activities for existing drug and medical device products to create savings for the Surgery business. The role works closely with regulatory affairs product owners and the cross-functional team to assess changes and author submissions to implement change globally. It is responsible for developing and communicating RA strategies related to BD Excellence for the Surgery Business Units products, including Advanced Repair & Reconstruction and Surgical Solutions product portfolios. Through collaboration with key stakeholders, the Staff Regulatory Affairs Specialist BD Excellence will negotiate with regulators and help ensure cost savings for the Surgery business. Job Description BD is one of the largest global medical technology companies in the world. We are dedicated to advancing health and creating transformative solutions. The Staff Regulatory Affairs Specialist BD Excellence is a strategic thought partner to the Business Unit, supporting productivity and collaborating with cross-functional partners to provide regulatory expertise. This role develops regulatory strategies that lead products through the FDA clearance/approval process, as well as other global regulatory agencies. Responsibilities Include Write drug and medical device regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), PMA supplements, 510(k)s, and Regulatory authority responses. Propose strategies on complex regulatory issues using technical regulatory skills. Determine deliverables for regulatory submissions and communicate with appropriate functional representatives to ensure timely and accurate submissions per business objectives. Collaborate with R&D, Manufacturing, Quality, and other areas to review regulatory strategy and impact of product changes. Support OUS RA team members to maintain effective collaboration and synchronize domestic and international submissions. Work with regulatory product owners to determine submission and approval requirements. Assess the acceptability of testing and documentation for submission filing. Negotiate and interact with regulatory authorities during the review process to secure submission approval. Build positive relationships with regulatory reviewers. Monitor changes in regulations and update internal partners on submission strategies. Submit and respond to applicable regulatory reports and inquiries. Submit/review change controls to determine the level of change and submission requirements. Strategize with and advise internal partners on regulatory issues and requirements. Conduct technical meetings with regulatory advisory committees and government agencies. Support and lead assigned improvement/productivity activities.
Skills/Knowledge
Knowledge of United States, European, and international regulations and standards covering medical devices. Demonstrated organizational, planning, and program management skills with action orientation and results focus. Experience in continuous improvement projects, project management, product development processes, and design control. Excellent project management abilities, including prioritization and multitasking. Ability to adapt to change and communicate risk and uncertainty effectively. Excellent written and verbal communication, including cross-cultural communication and negotiation with Regulators. Ability to interpret medical device and drug testing methods and statistics, as applicable. Knowledge of current and future policies, practices, trends, technology, and information affecting the business.
Required Qualifications
Bachelors degree in a technical field such as biology, chemistry, engineering or medical-related area.
Preferred Qualifications
5 years of experience in the medical device industry, with at least 3 years in a regulatory role. Advanced degree (Masters or PhD).
On-site collaboration is prioritized in this organization to foster creativity and problem-solving. For most roles, a minimum of 4 days in-office presence per week is expected to maintain our culture of excellence. Remote or field-based positions will have different workplace arrangements indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where permitted by law. Requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions, encourages you to be your authentic self, and supports learning and growth. BD aims to help you reinvent the future of health and find satisfaction in contributing to meaningful work. To learn more about BD, visit the BD Careers site. BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information $113,400.00 - $186,900.00 USD Annual Location USA RI - Warwick; USA IL - Vernon Hills Employment type Full-time Job function Legal Industry Manufacturing Additional job listings and referral prompts have been omitted for clarity and relevance. #J-18808-Ljbffr