Job Description Summary

Reporting to the Senior Manager, Regulatory Affairs, Microbiology, the Staff Regulatory Affairs Specialist is responsible for the preparation of strategies for moderately to highly complex regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to Core Teams and to functional staff to achieve rapid worldwide clearance/approval/registrations of products with desired claims and maintain compliant post-market change management. Represents BD in pivotal interactions/negotiations with regulatory agencies and participates in external efforts to influence policy making bodies and standards development organizations. Able to use project management tools to facilitate development and communication of predictable regulatory deliverables that maximizes opportunity for regulatory success.

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 moderately to highly complex submissions to FDA and other regulatory agencies. Prepares or coordinates the preparation of Pre-IDEs, PMA, PMA Supplements, 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.

• Represents the business in interactions with regulatory authorities. Plays a prominent role in complex negotiations regarding (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase.

• Prepares Technical Files for CE marking, to include obtaining documentation and support from Quality to maintain compliance, and interfaces as needed with Notified Bodies regarding significant changes to products. Provides subject matter expertise during Technical Audits by Notified Bodies to maintain design certificates.

• Organizes and manages meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings.

• 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 the impact 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 training or presentations in multiple disciplines to cross-functional groups across BD on salient regulatory topics.

• Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.

• Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas. Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.

• Independently manages and monitors multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision. Maintains a "focused urgency" as required by specific eve