Description
DescriptionInternational Regulatory Affairs (RA) Manager is responsible for managing international registration, tender and import related regulatory activities, supporting new product RA and current business RA groups in interpreting and providing international regulatory requirements, ensuring department processes and procedures related to regulatory responsibilities are compliant, current and efficient, and managing and developing regulatory associates.Duties and Responsibilities:
- Manage and complete international registration, tender and import related regulatory activities per plan with minimal supervision:
a. Plan international support workload via tools such as iRAOP
b. Provide timely support to international regulatory associates' requests for information/documentation, including CFGs
c. Lead projects resulting in successful international registrations
d. Responsible for ship hold and lifting ship holds
e. Develop, monitor, and report to upper management key performance indicators
f. May manage teams chartered with addressing issues of international registrations (e.g., missing data, new requirements, etc.) - Provide regulatory expertise in international regulatory requirements:
a. Act as a main liaison for international regulatory requirements
b. Support New Product RA and Current Business RA by providing international regulatory requirements to GPDS projects and sustaining projects
c. Monitor changes in international regulatory requirements, and perform and communicate the change impact on BDB to upper management - Ensure RA department processes and procedures related to regulatory responsibilities are compliant, current and efficient
a. Ensure electronic systems are kept up-to-date and used: iRAOP, eGPS, Tech File structure in SAP, DoC in Caliope, etc.
b. Responsible for ensuring Regulatory policies, SOPs and Desk Procedures are properly developed, approved and maintained, e.g., international registration matrices, eGPS process, etc.
c. Continue to seek and implement CI projects to gain efficiency - Manage and develop regulatory associates
a. Develop individual goals (IIGs) and development goals for associates
b. Ensure a high standard of performance is met by providing timely feedback on associates' performance and driving associate training, development, and engagement activities
c. Promotes a safe work environment - Review product labeling, advertising and promotional materials
- Provide Regulatory support to regulatory inspections, such as ISO and FDA audits
- May lead cross-functional or cross-business teams to address process improvements, major international regulatory changes or initiatives (e.g., compliance with new registration requirements in developing markets), or professional development with minimum supervision
- Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDD 98/79/EC, MDD 93/42/EEC, 21 CFR 820, global registration and import regulations, import/export, GCP, GLP, BD Corporate policies/procedures, EU standards and directives, applicable ISO standards, Japanese (PAL), China Medical device, applied statistics, and technical writing
- Performs other duties and assignments as required
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