Job Description Summary

The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BD Point of Care products with desired claims. Proficient project/people management skills, establishes/achieves schedules and milestones for functional projects, provides performance feedback. Represents BD Point of Care 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. 

Key responsibilities will include: 

• 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.

• Prepares or provides input into Technical Files for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.

• 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. 

• 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 how these impact 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 a variety of 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 events.

• Inspires effective unit dynamics and imparts a sense of commitment to unit goals.  Encourages and empowers others to achieve.  Recognized as a leader within division (for example PDT, business or unit LT, RLT, RSC).

• Formulates short term planning for individual deliv