Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Define, lead, and personally implement global strategies for regulatory and product data.

• Engage in hands-on management of product attributes, certifications, and compliance requirements specific to various countries within the realm of regulatory information management.

• Ensure ongoing compliance with global regulatory standards and maintain data accuracy for commercialization activities.

• Create, uphold, and execute governance frameworks for global regulatory and product data.

• Provide senior-level leadership in regulatory matters while overseeing regulatory and product data for global submissions.

• Conduct and review activities related to data validation, reconciliation, tracking, and reporting for the product portfolio.

• Lead and assist in the design, implementation, and daily operations of global distribution control and transitional strategies.

• Collaborate with cross-functional teams to facilitate compliant product releases and address any issues.

⛳️ Requirements

• Demonstrated ability to lead intricate regulatory initiatives while engaging in detailed, hands-on regulatory and data management tasks.

• Strong leadership, influence, and execution capabilities, with the adaptability to shift smoothly between strategic planning and tactical implementation.

• Exceptional attention to detail along with outstanding analytical, problem-solving, and organizational abilities.

• Proficient in Excel and data manipulation or reporting tools.

• Strong written and verbal communication skills.

• Bachelor’s degree in a scientific, engineering, or regulatory discipline (or equivalent experience).

• At least 8 years of experience in Regulatory Affairs, Regulatory Operations, data management, or a compliance-focused environment.

• Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks.

• Prior experience in product data management, ERP, or distribution control systems, including familiarity with ERP execution and workflows (e.g., SAP).

• Experience with Master Data Management principles and tools.

• Understanding of UDI requirements, CE marking, and country-specific licensing processes.

• Proven ability to collaborate effectively across functions in a global, regulated organization.

🏝️ Benefits

• Comprehensive Total Rewards program

• Reward and recognition opportunities that promote a performance-based culture

• Competitive package of compensation and benefits programs