Senior Regulatory Affairs Specialist, Bedford
Client:
Werfen Location:
Bedford, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
1acfe3403668 Job Views:
89 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Overview Werfen Werfen is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. Position Summary: Responsible for China NMPA and Japan PMDA registration and renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain regulatory compliance. Responsibilities Key Accountabilities: Participate on design and risk management teams as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements. Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications. Prepare new product registration packages for China NMPA and Japan PMDA. Assist with product renewal packages to maintain country registrations. Provide technical review of data or reports for regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Responsible for maintenance of Regulatory Database in SAP. Responsible to review marketing and promotional materials. Educate and train IL personnel on international registration and labeling requirements. Other assignments related to RA/QA to support Werfen requirements and priorities. Networking/Key relationships: Develop relationships working with domestic and international Quality, Regulatory, R&D, Marketing and Operations teams. Skills & Capabilities: Excellent communication skills to facilitate agreement/coordination between different groups/departments. Knowledge in NMPA and PMDA medical device regulations. Ability to prioritize and plan work with minimal supervision in a fast-paced environment. Qualifications Minimum Knowledge & Experience required for the position Education:
Bachelor's degree in engineering or science, advanced degree preferred. Experience: Minimum of 5 years' experience in the medical device industry (in-vitro diagnostics a plus). Experience in the preparation of technical submissions to obtain NMPA and/or PMDA regulatory approval. Demonstrated understanding of NMPA Decree and related regulations. Additional skills/knowledge: Effective verbal and written communication. Excellent analytical and strategic thinking skills. RAC certification is a plus. Language fluency: English and Chinese essential. International Mobility:
Required: No Travel Requirements:
Available to travel domestically and internationally as needed. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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Client:
Werfen Location:
Bedford, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
1acfe3403668 Job Views:
89 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Overview Werfen Werfen is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. Position Summary: Responsible for China NMPA and Japan PMDA registration and renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain regulatory compliance. Responsibilities Key Accountabilities: Participate on design and risk management teams as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements. Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications. Prepare new product registration packages for China NMPA and Japan PMDA. Assist with product renewal packages to maintain country registrations. Provide technical review of data or reports for regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Responsible for maintenance of Regulatory Database in SAP. Responsible to review marketing and promotional materials. Educate and train IL personnel on international registration and labeling requirements. Other assignments related to RA/QA to support Werfen requirements and priorities. Networking/Key relationships: Develop relationships working with domestic and international Quality, Regulatory, R&D, Marketing and Operations teams. Skills & Capabilities: Excellent communication skills to facilitate agreement/coordination between different groups/departments. Knowledge in NMPA and PMDA medical device regulations. Ability to prioritize and plan work with minimal supervision in a fast-paced environment. Qualifications Minimum Knowledge & Experience required for the position Education:
Bachelor's degree in engineering or science, advanced degree preferred. Experience: Minimum of 5 years' experience in the medical device industry (in-vitro diagnostics a plus). Experience in the preparation of technical submissions to obtain NMPA and/or PMDA regulatory approval. Demonstrated understanding of NMPA Decree and related regulations. Additional skills/knowledge: Effective verbal and written communication. Excellent analytical and strategic thinking skills. RAC certification is a plus. Language fluency: English and Chinese essential. International Mobility:
Required: No Travel Requirements:
Available to travel domestically and internationally as needed. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
#J-18808-Ljbffr
