Senior Regulatory Affairs Specialist

2 months ago

Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen, founded in , 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, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

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:

Responsible to participate on design and risk management teams (both Hemostasis and Acute Care) as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, including:

Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input. Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output. Prepare new product registration packages for China NMPA and Japan PMDA. Provide support materials for Milan Regulatory for other country registrations. Assist with product renewal packages to maintain country registrations. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards. Responsible for maintenance of Regulatory Database in SAP. Responsible to review marketing and sign promotional materials for signature by management (as appropriate). Responsible to review and sign labeling and Change Orders (as appropriate). Educate and train IL personnel on international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated. Other assignments related to RA/QA to support Werfen requirements and priorities.

Networking/Key relationships:

To be determined based on department needs. This individual needs to develop relationships working with the domestic and international Quality, Regulatory, R&D, Marketing and Operations teams.

Skills & Capabilities:

Effective decision maker Excellent communication skills to facility agreement/coordination between different groups/departments Knowledge in NMPA and PMDA medical device regulations Act as an advisor and educator to Company on NMPA and PMDA regulations and requirements Ability to prioritize and plan work with minimal supervision in a fast-pace environment.

Qualifications

Minimum Knowledge & Experience required for the position 

Education: Bachelor's degree in engineering or science, advanced degree

Experience:

Minimum of 5-years' experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience Experience in the preparation of technical submission to obtain NMPA and /or PMDA regulatory approval. Demonstrated understanding of NMPA Decree along with its lower-level regulations pertaining to the QMS and other general product registration matters, as well as CFR 21 /ISO requirements. Additional skills/knowledge: Effective verbal and written communication in individual and group settings Excellent analytical and strategic thinking skills Strong project management skill Cross-cultural project experience a plus RAC certification is a big plus Language fluency: English and Chinese essential

International Mobility: Required:

No

Travel Requirements: 

Available to travel domestically and internationally as needed.

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