We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM 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.
Requirements
- Drive continuous improvement initiatives and develop, under the oversight of the Sr Director Regulatory WWIPD, Regulatory strategies to enhance product quality design, regulatory compliance and customer satisfaction
- Responsible for outside of the U.S. Infusion disposable sets to ensure a system-level approach between pumps and sets, including alignment and consistency in regulatory strategy, communication with regulatory bodies and change control determination
- Act as the interface on behalf of the Sr Director Regulatory WWIPD between Worldwide IPD and MMS for Design regulatory continuity
- Lead multi-departmental and business unit teams to implement the regulatory strategies set by the Sr Director Regulatory WWIPD, with respect to the collection, documentation, analysis, and reporting of information for inclusion in Worldwide submission
- Supports members of the WW IPD Regulatory Leadership Team
- Responsible for product labeling, promotional claims, and advertisements to ensure compliance with U.S. and international laws and regulations
- Manage Regulatory Affairs platform and leads a team of Regulatory professionals in the US in alignment with the mission and vision set by the Sr Director Regulatory WWIPD
- Support change control processes and problem solving expertise to mitigate risks
- Partners proactively in product development design to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products in concert with the commercialized recommendations provided by Sr Director Regulatory WWIPD
- Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape
- Serves as subject matter expert on corporate initiatives in support of executive leadership team initiatives on behalf of the Sr Director Regulatory WWIPD
- Prepares, coordinates, and manages regulatory audits such as 510Ks audits, and ensures timely responses to questions, non-conformities or otherwise
- Builds relationships with key advocates, regulators and internal/ external stakeholders to ensure that BD point of view is understood and carried forward
- Act as a subject matter expert (SME) at the site and functional level
- Ability to interpret medical device testing methods and statistics, as applicable
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
