Job Description Summary

The Staff Regulatory Affairs Specialist is responsible for regulatory review and strategies for routine, moderate and highly complex post-market changes and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This associate will provide regulatory guidance to cross-functional business teams, change control review boards and coordinate support for sustaining engineering teams concerning regulatory requirements for notification, submission and compliant implementation of proposed changes to products and processes.
Provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BDDS Molecular Diagnostics products with desired claims
Proficient project/people management skills, establishes/achieves schedules and milestones for functional projects, provides performance feedback. Represents BDDS Molecular Diagnostics in pivotal interactions/negotiations with regulatory agencies and participates in external efforts to influence policy making bodies and standards development organizations.

Job Description

We are the makers of possible 

 

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. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities:

• Develops regulatory strategies for compliant implementation of proposed routine, moderately and highly complex changes to on-market products and processes. These strategies include seeking regulatory input from regional associates and formal communication of the proposed changes through the Notice of Change or Product Development Notification Process.
• Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Will prepare or coordinate the preparation of Pre-IDE, PMA, De Novo Petition, and 510(k) submissions. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.
• Provides risk-based regulatory assessments of strategies, guidances and regulatory compliance options to cross-functional business teams, Sustaining Engineering Teams and Change Control Review Boards.
• Responsible for preparing and submitting PMA Supplements for on-market US Class Ill Devices to include Manufacturing Site Changes, Special PMA Supplements for Changes Being Affected, 30-day Notices and Annual Reports for on-market US Class Ill devices. Coordinates with Regulatory Affairs Specialists pre-market to ensure post-market supplements minimize complexity to potential premarket submissions. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.
• Provide support in interactions with regulatory authorities concerning post-market compliance activities. Plays a prominent role in negotiations with Notified Bodies regarding (1) Technical File Audits and recertification processes and (2) notifiable changes made to CE marked products.
• Prepares or provides input into Technical Documentation Package for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.
• Provides regulatory affairs review, assessment, and guidance for convened routine and complex Situation Analyses Assessments as needed.
• Communicates (oral/written) with senior BD leadership as well as functional teams. Assesses and independently responds to feedback. Prepares formal written reports/documents for distribution within work unit and regions.
• Interprets statutes, regulations, policies and guidances for business teams and product development/support teams, communicating what the potential impacts are on product development, manufacturing, and/or marketing.
• Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business. Provides trainin