Krakow, Lesser Poland Voivodeship, Poland · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Regulatory Affairs, Quality Assurance, Product Management, GMP, Bioprocess Industry
Escambia County, Florida, United States · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Manufacturing, Cleanroom Operations, ERP Systems, SAP, Oracle
Beijing, Beijing, China · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At SCIEX, one of Danaher’s 15+ operating companies, our work saves lives—and …
Skills: Mass spectrometry, Electronics hardware, Troubleshooting, Calibration, Testing
Singapore, Singapore · Remote OK
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Emerson Delta V DCS, Siemens PLC, SCADA, AVEVA Wonderware, Automation Engineering
Incheon, South Korea · Remote OK
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Strategic Account Management, Sales Forecasting, Contract Negotiation, Market Insight, Customer Intelligence
Munsons Corners, New York, United States · On-site
$23/hr–$29/hr
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Pall Corporation, one of Danaher’s 15+ operating companies, our work save…
Skills: Machine Operation, Equipment Setup, Blueprint Reading, Manufacturing, Data Collection
Singapore, Singapore · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves…
Skills: Manufacturing, Machine Operation, Troubleshooting, EHS Compliance, Quality Assurance
Bangalore North, Karnataka, India · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our…
Skills: .Net, C#, WPF, Microservices, Cloud development
Pudong, Shanghai, China · On-site
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from f…
Skills: Process Engineering, Downstream Systems, Project Management, Systems Engineering, GMP Validation
Lixia District, Shandong, China · On-site
1、职责目的Position Objectives： 开发和维护食品饮料行业的客户，管理和协调经销商的业务活动，确保销售目标和利润指标的达成。 Develop and maintain F&B customers, manage and coordinate distributors business activities, ensure sales and profit targets achievement. 2、主要职责Key R…
Skills: Sales management, Business development, Key account management, Distributor management, Market analysis
Singapore, Singapore · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At SCIEX, one of Danaher’s 15+ operating companies, our work saves lives—and …
Skills: Mechanical engineering, Manufacturing engineering, Failure analysis, Root cause analysis, Lean manufacturing
Krakow, Lesser Poland Voivodeship, Poland · On-site
Bring more to life. Ready to accelerate your potential and make a real difference in life sciences, diagnostics, and biotechnology? At Cytiva, part of Danaher, our work helps save lives. We provide innovative solutions t…
Skills: People Leadership, Agile Execution, CI/CD, SDLC Controls, Enterprise Software Engineering
Osaka, Japan · Remote OK
Mission & Company Overview Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With over 80 years of history, we have remained a truste…
Skills: Electrical Engineering, Mechanical Engineering, Equipment Installation, Troubleshooting, Calibration
Yelahanka taluku, Karnataka, India · Remote OK
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, o…
Skills: Lead Qualification, CRM Management, Customer Journey Mapping, Digital Engagement, Sales Funnel Management
Yelahanka taluku, Karnataka, India · Remote OK
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, o…
Skills: Lead Qualification, CRM Management, Digital Marketing, Customer Journey Mapping, Written Communication
Newquay, England, United Kingdom · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Project management, Manufacturing engineering, Process improvement, Risk management, Business continuity planning
O'Callaghansmills, Killaloe Municipal District, Ireland · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our…
Skills: Technical Project Management, Supply Chain Management, NPI Execution, Clinical Chemistry, cGMP
Brea, California, United States · On-site
$140k–$155k/yr
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our…
Skills: Transfer Pricing, International Tax, Corporate Income Tax Compliance, Intercompany Transactions, OECD Guidelines
Boone County, Kentucky, United States · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our…
Skills: Forklift Operation, Reach Truck, Cherry Picker, Inventory Control, Cycle Counting
New Delhi, Delhi, India · Remote OK
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Phenomenex, one of Danaher’s 15+ operating companies, our work saves lives…
Skills: Account Management, Sales Negotiation, Chromatography, HPLC, Business Development
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The Regulatory Support Specialist provides quality and regulatory documentation to support product managers, regions, and customers. They are responsible for investigating regulatory issues, maintaining documentation databases, and ensuring compliance with bioprocess industry requirements.
Candidates must hold a Bachelor of Science degree in Chemistry, Pharmacy, or a related field. They should have 2-5 years of experience in Quality Assurance, Regulatory Affairs, or Product Management, along with a strong understanding of GMP.
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
We’re looking for a Regulatory Support Specialist to join Cytiva’s Customer Regulatory Support (CRS) team at our site. This will be an onsite role, based in Krakow.
Regulatory Support Specialist is responsible for providing support to Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers’ requests for quality, regulatory and technical-related information. As a member of the Customer Regulatory Support team, you will add value to bioprocess products and demonstrate a commitment to customer satisfaction.
What you will do:
Build and maintain knowledge and understanding of customers’ regulatory requirements related to the bioprocess business at a high level.
Develop and update regulatory support documentation for products in customers’ regulated environments.
Perform necessary investigations and prepare and deliver statements and certificates. Participate in creating and updating guidelines and steering documents.
Respond efficiently and promptly to customers’ regulatory based issues, which will include necessary investigations, preparations and delivery of certificates, use of available internal and external databases and other relevant databases.
File and maintain complete documentation of questions and answers in databases; specify, prepare, update and review regulatory support documentation, including RSF, VG, VSF, CCN, statements, certificates and other regulatory related documentation for new and existing products.
Approve accesses to customer portals.
Review and approve NDAs with customers.
Who you are:
Bachelor of Science degree in Chemistry, Pharmacy or related field.
2-5 years of experience from relevant positions within Quality Assurance, Regulatory, or Product Management.
Good understanding of GMP and knowledge of regulatory requirements in the bioprocess industry.
Excellent communication skills and fluency in English, both written and spoken.
It would be a plus if you also have:
Experience of working in large matrix organizations.
Fluency in the language of the country of employment.
Experience in customer communication.
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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. We partner with customers around the world to accelerate breakthroughs from idea to impact, moving with the speed and certainty they need to advance life‑changing science. By working side‑by‑side with researchers, scientists, and clinicians, we solve their hardest problems—together, bringing the right expertise, technologies, and partners from across our portfolio to architect the most effective solutions. Through our connected ecosystem of companies operating at global scale, we help customers streamline and integrate their workflows across Life Sciences, Diagnostics, Biotechnology, and beyond—empowering them to achieve results faster, with greater confidence.
Offices: 2200 Pennsylvania Ave NW, 800 W, Washington, District of Columbia 20037, US
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. We partner with customers around the world to accelerate breakthroughs from idea to impact, moving with the speed and certainty they need to advance life‑changing science. By working side‑by‑side with researchers, scientists, and clinicians, we solve their hardest problems—together, bringing the right expertise, technologies, and partners from across our portfolio to architect the most effective solutions. Through our connected ecosystem of companies operating at global scale, we help customers streamline and integrate their workflows across Life Sciences, Diagnostics, Biotechnology, and beyond—empowering them to achieve results faster, with greater confidence.
Offices: 2200 Pennsylvania Ave NW, 800 W, Washington, District of Columbia 20037, US
