Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Sr. Manager, Regulatory Affairs will lead, plan, coordinate, conduct and report on regulatory registration programs. This includes activities such as registration strategy for management of clearance/approval/registration/licensure documentation for submissions to regulatory agencies worldwide. This individual will execute department and cross functional projects, identify regulatory activities for project schedules, serve as a core team member/extended core team leader, and recommend appropriate actions on regulatory issues. In addition, provide assurance that processes and procedures related to regulatory responsibility are compliant, current and efficient.
The Sr. Manager, Regulatory Affairs solves problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors and interpretation. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
DUTIES AND RESPONSIBILITIES:
- Represents the function on designated core teams, and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including advertising and promotional materials) in the context of submissions or registrations, and serve as the regulatory expert on the projects.
- Develops and executes regulatory strategies for a range of complex new products with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.).
- Advocates least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements. With minimum supervision, coordinates and prepares regulatory submissions, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications.
- Manage regulatory affairs team members responsible for pre-market and post-market submissions
- Develops, monitors, and reports to senior management key performance indicators. Mentors regulatory associates and develop for career advancement.
- Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives (e.g., compliance with new registration requirements, or professional development with minimum supervision).
- Experience authoring FDA 510(k) submission a must. PMA a plus
- Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements
- Demonstrated self-starter and highly motivated, energetic and enthusiastic
- Driven leadership with an emphasis on talent development
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
- Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results
- Demonstrated ability to effectively formulate and drive change
- Experienced in continuous improvement projects, project management, and product development processes.
- Ability to be effective in complex projects with ambiguity and/or rapid change
- Excellent written and verbal communication 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.
- Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc.
- Computer literacy (Document management system like SAP, PC, Microsoft Word/Excel/PowerPoint)
- Willingness to travel up to 20% of the time (domestic and international)
Education and Experience:
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.). Advanced degree in life sciences (MS, PhD, etc.) and/or MBA encouraged. RAC encouraged.
- Minimum of 7 years of direct applicable regulatory experience in medical devices, IVD experience a plus. Proven leadership skills and presence.
- Minimum of 3 years managerial experience
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.
Primary Work LocationUSA CA - San Jose
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist