{"id":2061658,"url":"https://alion.io/job/werfen-senior-rd-technical-writer-transfusion","title":"Senior R&D Technical Writer - Transfusion","company":{"id":1839823,"name":"Werfen","domain":"werfen.com","url":"https://alion.io/company/werfen","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Product","role_family":"Product","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Norcross, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":112000,"max_usd":208000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2761},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"IVDR","optional":false},{"name":"Microsoft Office","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-10-08T02:14:04Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-28T08:06:43Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"Introduction\nWerfen 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.\nOur 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\nOverview\nWe 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!\nThis 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.\nResponsibilities\nAdditional responsibilities for Sr. R & D Technical Writer:\nResponsible for preparing all required R&D documentation for IVDR products to be in compliance with EU MDR 2017/746 regulation and/or FDA.\nReview current or new product documentation to develop strategies to align with cross-functional teams to fulfill the regulatory requirement.\nCollaborate with the Regulatory Affairs, Quality Control, Clinical Operations and Project Management organizations to determine requirements and draft/edit documentation for IVD products.\nDraft and develop plans, protocols and reports that explain and support the performance of a product to be in compliance.\nUnderstand basic system functionality and operation of instrumentation and reagents to populate plans and reports for the document of the product performance.\nIdentify and escalate potential document generation improvements to the respective organizations.\nSupport in proceeding the Audit (onsite or remote) activities by a competent Authority, as required by the team.\nEnsure, consistency, completeness, accuracy, and conformance to style guidelines.\nResponsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation.\nSupport responses to FDA and EU Notified Body during the preparation and review of submissions.\nStrong attention to detail with organizational and technical writing skills.\nMentor and assist in giving on-the-job training and instructions to junior staff \nAdditional Responsibilities:\nDemonstrates strong verbal and written communication skills.\nDisplays ability to communicate clearly, write technical documentation clearly, legibly fill out documentation to communicate data and details as needed.\nInteracts cooperatively with co-workers and receives direction well from managers.\nDisplays ability to be an effective team member.\nDemonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements.\nDisplays PC skills with Microsoft Office (Word and Excel) and other software applications (TrackWise, MasterControl, SharePoint) functions at an intermediate level.\nAbility to prioritize multiple workloads.\nInteracts effectively with other departments.\nMaintain records and files of work and revisions according to procedures and processes by following cGDP.\nQualifications\nOther qualifications for this role include:\nBS/BA in a related discipline, or advanced degree, where required, or equivalent combination of education and experience.\n3+ years of experience within a Regulated Industry (medical device / pharma preferred.)\nExperience working on multidisciplinary teams in a fast-paced, dynamic environment.\n3+ years of technical writing experience.\nClosing\nIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.\nWerfen 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  for assistance.\nWe 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.\nwww.werfen.com","description_format":"text","description_chars":5586,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care"],"lifecycle":[{"event":"open","at":"2026-10-08T02:14:04Z"}],"visa":[],"liveness":{"score":23,"band":"cold","label":"Long shot","p_open":1,"p_active":0.669,"p_room":0.35,"age_days":20,"expected_fill_days":10,"reasons":["conf:2","velocity","win:tail"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/werfen-senior-rd-technical-writer-transfusion","json_url":"https://alion.io/job/werfen-senior-rd-technical-writer-transfusion.json","meta":{"generated_at":"2026-10-28T12:15:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":16147,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1839823},"rest":"https://alion.io/mcp/rest/get_company?id=1839823"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwerfen-senior-rd-technical-writer-transfusion"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fwerfen-senior-rd-technical-writer-transfusion"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fwerfen-senior-rd-technical-writer-transfusion"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/werfen-senior-rd-technical-writer-transfusion\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-senior-rd-technical-writer-transfusion"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2061658}},{"tool":"search_jobs","arguments":{"company":"werfen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2061658},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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