Manager, Environmental Compliance leading Rockwell Automation's global environmental compliance program across industrial automation portfolio. Strategic leadership for regulatory execution and compliance governance.
About the role
- Regulatory Affairs Specialist ensuring compliance for global product distribution at BD. Responsible for maintaining high-quality regulatory data and collaborating across multiple functions.
Responsibilities
- Manage product data attributes, certificates, and country‑specific compliance requirements within internal product data management, distribution‑control, and regulatory information management systems.
- Ensure data accuracy, consistency, and traceability to support global registrations, product releases, and lifecycle changes.
- Partner with Regulatory colleagues to maintain regulatory and product data used for submissions to external regulatory databases, including GUDID and EUDAMED.
- Perform routine data entry, validation, reconciliation, tracking, and reporting activities to support audits, inspections, and internal reviews.
- Support the implementation and ongoing maintenance of new transitional distribution-control processes.
- Monitor data dependencies and identify risks or issues that could impact product availability or regulatory compliance.
- Partner closely with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) RA, In-Country RA, Supply Chain, Marketing, Labeling, Quality and IT/System Administration teams.
Requirements
- Strong attention to detail with excellent analytical, problem‑solving and organizational skills.
- Proficiency in Excel and data manipulation or reporting tools.
- Demonstrated ownership and accountability for assigned work.
- Self‑motivated, proactive, and adaptable with a continuous learning mindset.
- Ability to manage multiple priorities and stakeholders in a fast-paced, regulated environment.
- Results‑driven, diligent, and able to work independently.
- Strong written and verbal communication skills.
- Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience).
- Minimum of 3 years of experience in regulatory affairs, regulatory operations, data management, or a compliance‑driven environment.
- Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks.
- Familiarity with UDI requirements, CE marking, and country‑specific licensing processes.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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