Job description

Werfen is a growing, family-owned, innovative company founded in 1966 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 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 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 We are seeking a Sr. R & D Technical Writer who will be responsible for preparing technical documentation to support IVD design history files and regulatory submissions. Strong understanding of Quality Management Systems and Global IVD Regulations (including but not limited to IVDR and 21CFR820).driven and results-oriented Validation Engineer I to be responsible for assuring the successful execution of Werfen’s Validation Program. If you are interested in joining an organization where your talents and expertise will be highly appreciated, and if you meet our qualifications to excel in this position, we want to hear from you. Contact us today! This position is not eligible for sponsorship for work authorization . Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time . Job Responsibilities : • Responsible for preparing all required R&D documentation for IVDR products to be in compliance with EU MDR 2017/746 regulation and/or FDA. • Review current or new product documentation to develop strategies to align with cross-functional teams to fulfill the regulatory requirement. • Collaborate with the Regulatory Affairs, Quality Control, Clinical Operations and Project Management organizations to determine requirements and draft/edit documentation for IVD products. • Draft and develop plans, protocols and reports that explain and support the performance of a product to be in compliance. • Understand basic system functionality and operation of instrumentation and reagents to populate plans and reports for the document of the product performance. • Identify and escalate potential document generation improvements to the respective organizations. • Support in proceeding the Audit (onsite or remote) activities by a competent Authority, as required by the team. • Ensure, consistency, completeness, accuracy, and conformance to style guidelines. • Responsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation. • Support responses to FDA and EU Notified Body during the preparation and review of submissions. • Strong attention to detail with organizational and technical writing skills. • Mentor and assist in giving on-the-job training and instructions to junior staff Additional Responsibilities: • Demonstrates strong verbal and written communication skills. • Displays ability to communicate clearly, write technical documentation clearly, legibly fill out documentation to communicate data and details as needed. • Interacts cooperatively with co-workers and receives direction well from managers. • Displays ability to be an effective team member. • Demonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements. • Displays PC skills with Microsoft Office (Word and Excel) and other software applications (TrackWise, MasterControl, SharePoint) functions at an intermediate level. • Ability to prioritize multiple workloads. • Interacts effectively with other departments. • Maintain records and files of work and revisions according to procedures and processes by following cGDP. Minimum Experience required for the position : • BS/BA in a related discipline, or advanced degree, where required, or equivalent combination of education and experience. • 3+ years of experience within a Regulated Industry (medical device / pharma preferred.) • Experience working on multidisciplinary teams in a fast-paced, dynamic environment. • 3+ years of technical writing experience. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Requirements

Must-haves

Responsible for preparing all required R&D documentation for IVDR products to be in compliance with EU MDR 2017/746 regulation and/or FDA.
Review current or new product documentation to develop strategies to align with cross-functional teams to fulfill the regulatory requirement.
Collaborate with the Regulatory Affairs, Quality Control, Clinical Operations and Project Management organizations to determine requirements and draft/edit documentation for IVD products.
Draft and develop plans, protocols and reports that explain and support the performance of a product to be in compliance.
Understand basic system functionality and operation of instrumentation and reagents to populate plans and reports for the document of the product performance.
Identify and escalate potential document generation improvements to the respective organizations.
Support in proceeding the Audit (onsite or remote) activities by a competent Authority, as required by the team.
Ensure, consistency, completeness, accuracy, and conformance to style guidelines.
Responsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation.
Support responses to FDA and EU Notified Body during the preparation and review of submissions.
Strong attention to detail with organizational and technical writing skills.
Mentor and assist in giving on-the-job training and instructions to junior staff
Demonstrates strong verbal and written communication skills.
Displays ability to communicate clearly, write technical documentation clearly, legibly fill out documentation to communicate data and details as needed.
Interacts cooperatively with co-workers and receives direction well from managers.
Displays ability to be an effective team member.
Demonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements.
Displays PC skills with Microsoft Office (Word and Excel) and other software applications (TrackWise, MasterControl, SharePoint) functions at an intermediate level.
Ability to prioritize multiple workloads.
Interacts effectively with other departments.
Maintain records and files of work and revisions according to procedures and processes by following cGDP.
BS/BA in a related discipline, or advanced degree, where required, or equivalent combination of education and experience.
Experience working on multidisciplinary teams in a fast-paced, dynamic environment.

Nice-to-haves

3+ years of experience within a Regulated Industry (medical device / pharma preferred.)

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: icims
Effort: medium

Benefits

Benefits detected in the listing.

Vision