Regulatory Affairs Specialist, Digitalization

We are the people who give possibilities purpose

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 Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Regulatory Affairs Specialist, Digitalization is responsible for executing and maintaining the central regulatory affairs activities and work across BUs and Regions, specifically for the eIFU Qarad system. This role is accountable for supporting a comprehensive digital regulatory system that accelerates innovation, enhances operational excellence, and enables data-driven decision-making across business units and regions.

The role has responsibilities for the management, maintenance, and improvements of the eIFU Qarad system operated and utilized by Regulatory Affairs related to Product Information Management. The Regulatory Affairs Specialist, Digitalization will work with SMEs and stakeholders from Central, BU and Regional teams to ensure user needs are identified and met. Coordinates with cross-functional teams and departments to incorporate global regulatory strategy into GPDS (digital solution).

Supports BU digital center of excellence.

Through exceptional communication, cross-functional collaboration, and agile problem-solving, the RA Specialist partners with the Senior RA Manager, Digitalization, Product Information Management and senior leadership to refine the Regulatory Affairs vision, identify transformative opportunities, and lead high-impact initiatives that elevate BD's quality standards and customer trust.

Job Responsibilities:

(Primary Duties, Roles, and/or Authorities)

Primary Responsibilities:

* Support Global RA Digital Platforms:
Supports the Regulatory Affairs digital platform of product information management.

* Support the Digital RA Portfolio:
Oversee digital regulatory platform(s), ensuring timely delivery, measurable outcomes, and stakeholder alignment.

* Form Cross-Functional Partnerships:
Partner with TGS, ISC, and Business Unit teams to co-create and implement initiatives and digital solutions from concept through deployment.

* Help Define and Align Key Driver Goals:
Support regulatory function goals with the Regulatory Leadership Team and lead, where applicable, initiatives to achieve measurable outcomes across global teams.

* Support RA System Optimization:
Collaborate central teams, business units and regional partners to implement a flexible, efficient, and scalable technology. Leverage digital tools and automation to enhance system flexibility, operational efficiency, and global harmonization.

Minimum Requirements:

* Bachelor's degree in science, engineering, or technology discipline required.

* Minimum of 3 years in Medical Device industry.

* Minimum of 5 years working with IT to launch and maintain systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards.

Preferred Qualifications:

* Master's degree in business, management, or technology related field.

* Minimum of 3 years in Medical Device industry, with roles in Regulatory Affairs and/or Quality Systems is preferred.

Knowledge and

Skills:

* Organization & Planning:
Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.

* Problem Solving, Analytical Skills and Professional Judgement:
Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.

* Decision Quality:
Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action.

* Communication

Skills:

Skilled facilitator for small and large…