Associate Specialist - Regulatory Affairs

1w1 week ago

Irvine, US · Full-time · $66,000 – $110,000

About this role

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose. The Advanced Patient Monitoring Regulatory Affairs team seeks a detail-oriented and proactive Regulatory Affairs Associate Specialist to support global product distribution and ensure ongoing regulatory compliance.

This role manages product data attributes, certificates, and country-specific compliance requirements within internal product data management, distribution-control, and regulatory information management systems. You will ensure products meet applicable regional regulatory requirements. Accurate, validated data will support global commercialization activities, including submissions to GUDID and EUDAMED.

Maintain accurate product and regulatory data to safeguard global distribution and adherence to local, regional, and international standards. Collaborate closely with cross-functional teams including Master Data Management, Corporate and Business Unit Regulatory Affairs, International RA, Supply Chain, Labeling, Marketing, IT, and Quality. Play a key part in optimizing internal distribution-control processes and regulatory systems.

Join an environment where you’ll be supported to learn, grow, and become your best self. Review processes, systems, and documentation to identify improvement opportunities. Become a maker of possible with BD’s global teams.

Requirements

Detail-oriented and proactive approach to regulatory compliance
Knowledge of product data attributes, certificates, and country-specific compliance requirements
Proficiency in internal product data management, distribution-control, and regulatory information systems
Familiarity with regulatory databases such as GUDID and EUDAMED
Ability to perform data entry, validation, tracking, and reporting
Skill in data analysis and generating accurate reports and insights
Experience reviewing processes and systems for improvement opportunities

Responsibilities

Collaborate with the Regulatory Affairs team to ensure accurate and compliant product information
Partner with Master Data Management, Corporate RA, APM RA, In-Country RA, Supply Chain, Marketing, Labeling and Quality to maintain high-quality product data
Support the implementation and ongoing maintenance of new transitional distribution-control processes
Coordinate with cross-functional teams to enable the timely and compliant release of products
Perform data entry, data validation, tracking, and reporting within regulatory systems
Develop expertise as a power user of internal product data management and distribution-control systems
Provide subject-matter expertise, data collection support, and submission coordination for system users
Collect, analyze, and interpret data to generate accurate reports and insights