BD
Overview
We are the makers of possible. The Regulatory Affairs (RA) Director is responsible for the management and setting the direction for the Medication Delivery and Vascular Care (MDVC) business platform within the Medication Delivery Solution Business Unit. The RA Director develops and implements regulatory strategies and submissions in support of global marketing within the MDVC platform. The RA Director works with external contacts, US and international regulatory authorities, physician advisors, and key industry specialists related to the product platform. The RA Director must stay knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. A minimum in-office presence is required to maintain our culture, while recognizing the importance of flexibility and work-life balance. Responsibilities
Manages and directs work for multiple product families, RA projects, or a Regulatory Affairs Platform. Provides regulatory leadership for the respective platform, product families, or RA program(s), and manages RA managers and individuals working within areas of responsibility. Recruits, develops, and manages RA professionals with varying levels of seniority and ensures regulatory milestones are met. Manages and directs the RA Professionals within the respective platform(s) or programs, structuring projects to ensure efficient completion. Develops managers and technical leaders by assessing capabilities, providing feedback, coaching, and mentoring. Manages budget related to Platform and/or projects, including submission costs, travel, and training for teammates. Partners in the product development process to provide strategic guidance from exploratory phases through ongoing compliance for commercialized products. Represents Regulatory in Business Unit meetings and product reviews. Anticipates detailed regulatory expectations for approval, including changes in the regulatory landscape. Manages communications and negotiates with regulatory agencies on behalf of the business. Assesses impact of studies and data on project outcomes and manages submission content. Influences all parties to ensure successful submission outcomes. Coordinates with Quality function on recall strategies and responses to quality audit findings. Ensures consistency of messages in advertising and promotional materials. Develops and approves regulatory policies, goals, and executive reports. Communicates internal Regulatory Affairs procedures and policies as needed. Represents RA in due diligence and product acquisition teams. Develops and influences government position in partnership with Legal and Government Affairs. Builds relationships with key regulators and stakeholders to carry BD’s point of view forward. Qualifications
Bachelor’s degree or advanced degree in biology, chemistry, engineering or a medical-related field with a minimum of nine years of experience, or equivalent combination of education and experience. Preferred minimum of ten to fifteen years in the medical device industry, with at least nine years in a regulatory role. Comprehensive knowledge of United States, European, and international regulations and standards for medical devices. Strong organizational, planning, and program management skills with a result-oriented mindset. 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 handle risk and uncertainty. Prior management experience. Ability to exercise independent judgment within a broad range of policies and practices. Ability to work on complex projects with ambiguity and rapid change. Self-starter with high motivation; excellent written and verbal communication skills across cultures; ability to interact with technical personnel and regulators. Ability to interpret medical device testing methods and statistics as applicable. Knowledge of current and future regulatory policies, practices, trends, and technology affecting the business. Advance degree preferred; RAC certification is a plus. Experience with Clinical Trial applications (US IDE). Medical device experience in Medication Delivery and/or Combination Products. Policy notices:
For certain roles, employment is contingent upon providing proof of full COVID-19 vaccination where required by location. In some locations, testing may be available or required. Accommodation requests will be considered under applicable law. Salary information
and location: Salary range information is provided below and varies by location. Salary or hourly rate ranges are based on experience, education, skills, and location.
Salary Range Information : $187,400.00 - $337,300.00 USD Annual. Location : Primary work location in the USA: NJ - Franklin Lakes; Additional location: USA UT - Salt Lake City BAS. 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 status, or any other protected status.
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We are the makers of possible. The Regulatory Affairs (RA) Director is responsible for the management and setting the direction for the Medication Delivery and Vascular Care (MDVC) business platform within the Medication Delivery Solution Business Unit. The RA Director develops and implements regulatory strategies and submissions in support of global marketing within the MDVC platform. The RA Director works with external contacts, US and international regulatory authorities, physician advisors, and key industry specialists related to the product platform. The RA Director must stay knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. A minimum in-office presence is required to maintain our culture, while recognizing the importance of flexibility and work-life balance. Responsibilities
Manages and directs work for multiple product families, RA projects, or a Regulatory Affairs Platform. Provides regulatory leadership for the respective platform, product families, or RA program(s), and manages RA managers and individuals working within areas of responsibility. Recruits, develops, and manages RA professionals with varying levels of seniority and ensures regulatory milestones are met. Manages and directs the RA Professionals within the respective platform(s) or programs, structuring projects to ensure efficient completion. Develops managers and technical leaders by assessing capabilities, providing feedback, coaching, and mentoring. Manages budget related to Platform and/or projects, including submission costs, travel, and training for teammates. Partners in the product development process to provide strategic guidance from exploratory phases through ongoing compliance for commercialized products. Represents Regulatory in Business Unit meetings and product reviews. Anticipates detailed regulatory expectations for approval, including changes in the regulatory landscape. Manages communications and negotiates with regulatory agencies on behalf of the business. Assesses impact of studies and data on project outcomes and manages submission content. Influences all parties to ensure successful submission outcomes. Coordinates with Quality function on recall strategies and responses to quality audit findings. Ensures consistency of messages in advertising and promotional materials. Develops and approves regulatory policies, goals, and executive reports. Communicates internal Regulatory Affairs procedures and policies as needed. Represents RA in due diligence and product acquisition teams. Develops and influences government position in partnership with Legal and Government Affairs. Builds relationships with key regulators and stakeholders to carry BD’s point of view forward. Qualifications
Bachelor’s degree or advanced degree in biology, chemistry, engineering or a medical-related field with a minimum of nine years of experience, or equivalent combination of education and experience. Preferred minimum of ten to fifteen years in the medical device industry, with at least nine years in a regulatory role. Comprehensive knowledge of United States, European, and international regulations and standards for medical devices. Strong organizational, planning, and program management skills with a result-oriented mindset. 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 handle risk and uncertainty. Prior management experience. Ability to exercise independent judgment within a broad range of policies and practices. Ability to work on complex projects with ambiguity and rapid change. Self-starter with high motivation; excellent written and verbal communication skills across cultures; ability to interact with technical personnel and regulators. Ability to interpret medical device testing methods and statistics as applicable. Knowledge of current and future regulatory policies, practices, trends, and technology affecting the business. Advance degree preferred; RAC certification is a plus. Experience with Clinical Trial applications (US IDE). Medical device experience in Medication Delivery and/or Combination Products. Policy notices:
For certain roles, employment is contingent upon providing proof of full COVID-19 vaccination where required by location. In some locations, testing may be available or required. Accommodation requests will be considered under applicable law. Salary information
and location: Salary range information is provided below and varies by location. Salary or hourly rate ranges are based on experience, education, skills, and location.
Salary Range Information : $187,400.00 - $337,300.00 USD Annual. Location : Primary work location in the USA: NJ - Franklin Lakes; Additional location: USA UT - Salt Lake City BAS. 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 status, or any other protected status.
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