Regulatory Affairs Specialist

1w1 week ago

Irvine, US · Full-time · $80,600 – $133,000

About this role

BD is one of the largest global medical technology companies, advancing the world of health with billions of MedTech products yearly. The Advanced Patient Monitoring Regulatory Affairs team seeks a detail-oriented and proactive Regulatory Affairs Specialist. This role supports global product distribution and ensures ongoing regulatory compliance through high-quality data management.

You will manage product data attributes, certificates, and country-specific compliance requirements in internal systems like product data management and regulatory information management. Ensure products meet regional regulatory requirements and support submissions to databases such as GUDID and EUDAMED. Accurate, validated data enables compliant global commercialization and lifecycle management.

The position requires collaboration with cross-functional teams including Master Data Management, Corporate and Business Unit Regulatory Affairs, International RA, Supply Chain, Labeling, Marketing, IT, and Quality. Operate with moderate autonomy applying regulatory data expertise to support efficient business operations. Maintain accurate product and regulatory data to safeguard global distribution.

Join an environment where the human element drives evolution across global teams. Be supported to learn, grow, and become your best self. Become a maker of possible with BD, turning impossible challenges into transformative solutions.

Requirements

Detail-oriented and proactive approach to regulatory tasks
Expertise in regulatory and product data management
Knowledge of global regulatory requirements and country-specific compliance
Proficiency with internal systems for product data, distribution-control, and regulatory information management
Experience supporting submissions to regulatory databases like GUDID and EUDAMED
Ability to perform data validation, reconciliation, and reporting
Skill in identifying data quality improvements and governance opportunities
Moderate autonomy in cross-functional collaboration

Responsibilities

Ensure data accuracy, consistency, and traceability to support global registrations, product releases, and lifecycle changes
Partner with Regulatory colleagues to maintain data for submissions to external databases including GUDID and EUDAMED
Perform routine data entry, validation, reconciliation, tracking, and reporting for audits, inspections, and reviews
Identify opportunities to improve data quality, efficiency, and regulatory data governance
Support implementation and maintenance of transitional distribution-control processes
Coordinate with cross-functional teams to enable timely and compliant product releases
Monitor data dependencies and identify risks impacting product availability or compliance

Benefits

Supported environment to learn, grow, and become your best self
Collaborative global teams across design, engineering, manufacturing, and marketing
Opportunity to contribute to transformative health solutions