北京招聘

Job Description Summary:
Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
Job Description:

RESPONSIBILITIES

• Works with project teams for New Product Development, Sustaining, and cost-saving projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project.
• Assists in the preparation of regulatory submissions.
• Identifies specific NMPA requirements, updates, and information as it relates to Devicor’s business.
• Completes reviews of labeling content, product and process changes, and product documentation.
• Maintains regulatory files in a format consistent with requirements.
• Analyzes support data for claims verification.
• Develops processes and checklists and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling promotional materials, and assuring the validity of regulatory compliance issues.
• Collaborates and assists the Global Regulatory Team to support product compliance internationally.
• Maintains the listing of relevant Chinese standards.
• Identifies specific changes in global regulations, develops strategies for compliance, and provides updates of upcoming changes as appropriate.
• Provides regulatory support for internal and external (Regulatory Agency) audits and assists with resolving observations.
• Evaluates and implements procedures pertaining to corporate and departmental regulatory activities.
• Other duties as assigned.

In December 2014, Devicor？ Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients