We are the people who give possibilities purpose

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.

Job Description

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

• Lead cross functional team while demonstrating leadership in preparing and executing submissions including PMA, 510(k), NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses. Act as liaison with FDA regarding product submissions. 

• Represents RA and demonstrates leadership in product development team(s). Responsible for completion of regulatory strategies, review and approval of design control-related documents. 

• Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.

• Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.

• Implement company and departmental goals, objectives, and enforce requirements of quality work. Ensure RA department processes and procedures related to regulatory responsibilities are compliant, current and efficient.

• Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions.

• Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.

• Manage and maintain the drug and device registrations and listings (FURLS/DURLS) system.

• Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US.

• Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.

• Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders. 

• Ability to be effective in complex projects with ambiguity and/or rapid change. 

• Provides regulatory support during internal/external audits and inspections. 

Education and Experience:

• Bachelor’s degree or advanced degree in technical areas such as biology, chemistry, engineering or medical-related field and a minimum of five years of experience, with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies.

• Excellent organizational and communications skills.

• Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required. Experience navigating FDA databases required. Experience with electronic submissions and ERP systems is preferred.

Knowledge and Skills:

Required Qualifications:

• Proficient in using Microsoft Word, Excel, PowerPoint, OneNote, Adobe Acrobat PRO and Project. 

• Must be able to handle multiple tasks with attention to detail with limited supervision. 

• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills. 

• Project management of regulatory submissions with minimal guidance

• Proven ability to resolve problems and to make appropriate regulatory decisions. 

• Excellent oral and written communications skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators. 

• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, including analytical problem solving. 

• Comprehensive knowledge of US drug regulations, ICH guidelines, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations. 

• Proven background managing complex and strategic regulatory projects from initiation to conclusion.

• Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.

Preferred Qualifications:

• Advanced degree

• Knowledge/Expertise of Quality Systems.

• Experience with EU MDR.

Physical Demands: (if applicable)

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.  Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.  Upon request, the company may make reasonable accommodations.

Work Environment: (if applicable)

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company 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 or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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