- Location
- POL – Krakow – Cytiva, Poland
- Workplace
- Onsite
- Type
- Full-time
- Department
- Legal
- Seniority
- Senior
- Experience
- 2+ years
- Source
- Workday
Description
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.
The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva.
This position is part of Medical Regulatory Affairs and will be based on-site in Poland, Kraków. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
Manage assessments related to product change control and updates to applicable ISO standards, including monitoring of follow up actions to ensure ongoing regulatory compliance for medical devices.
Oversee global processes related to regulatory activities, specifically regulatory assessment of medical device product complaints and supply disruption reporting.
Provision of high-quality customer requests for regulatory information.
Participate with the implementation of new systems for regulatory processes and support team with regulatory RIM system.
Support regulatory audits for Cytiva sites that are related to medical devices (such as Regulation (EU) 2017/745 for Medical Devices, MDSAP, ISO 13485).
Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
You have a Life Sciences degree or equivalent.
You have 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
Comprehensive knowledge of Quality Systems which ensure that products, processes, and services consistently meet the desired quality and regulatory standards for medical devices, including as a minimum compliance to ISO 9001 and ISO 13485.
Working knowledge of Medical Device regulations and product compliance standards that apply globally for Cytiva’s medical device portfolio.
Good attention to detail.
Excellent oral and written communication, strengthened with fluency in English and Polish language.
Ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel required at 10% or less within the EMEA region.
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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.
