Regulatory Affairs Specialist II

3 weeks ago

Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7, strong.

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.

Position Summary:

Responsible for domestic and/or international registration and renewal activities for Werfen-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 domestic and international compliance.

Responsibilities

Essential Functions:

Responsible to participate on design and risk management teams (both Hemostasis and Acute Care Diagnostics) as the Regulatory representative and provide guidance on domestic and international requirements, including:

Responsible for providing deliverables for the submission of product registration and approval. Responsible for supporting non-US product registrations (Korea, Taiwan, India, EU, UK, Switzerland, etc.) preparing summary information, memos or statements (including CFG's; certifications, apostille, and consularization). Provide support in the continuation of annual renewals, Example: FDA Site Registration, MDL, MDEL, etc. Responsible for FDA device listings and GUDID entry. Attend design change meetings, provide guidance regarding registration impact for a change to an existing medical device. Ensure registrations are completed before releasing products into markets where there is impact. Submit notification to Notified Body about updates and changes to existing products. File MDR/MPR/Incident Reports (US/Canada/Notified Body-EU) Coordinate Mandatory Field Notifications / Correction and Removals - Interact closely with Customer Service, Service, R&D, QA to facilitate required action Maintain License Database for key markets. Responsible for Post Market Surveillance Reports to comply with EU and Canadian requirements.

Budget Managed (if applicable):

N/A

Internal Networking/Key Relationships:

To be determined based on department needs

Skills & Capabilities:

Requires superior communication skills (verbal and written) Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.) Experience with SAP is a plus.

Qualifications

Minimum Knowledge & Experience Required for the Position:

Requires a Bachelor degree, preferably in life sciences or engineering Familiarity with ISO and preferred Two years minimum experience in the Medical Device Industry or other highly regulated environment.

International Mobility: Required:

No

Travel Requirements: 

Must be available to travel domestically and internationally as needed.

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