Jobs Companies Danaher Regulatory Support Specialist (f/d/m)

Sobre este puesto de Regulatory Support Specialist (f/d/m) en Danaher

Danaher · Presencial · Krakow, Poland

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.

#LI-MK2

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.

¿Listo para postularte en Danaher?
Postúlate en Danaher

Sobre Danaher

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here .

Ver todos los empleos en Danaher →

Empleos similares

Danaher
Credit Control Assistant Accountant
Danaher
⚡ Postúlate pronto Sydney, New South Wales, Austr... Presencial
● Nuevo 👁 Visto ✓ Postulado hace 18h
Danaher
Freight and Logistics Specialist
Danaher
⚡ Postúlate pronto Torrance, California, United S... Presencial $80,000–$90,000
● Nuevo 👁 Visto ✓ Postulado hace 18h
Danaher
Operations Team Lead -Night Shift
Danaher
⚡ Postúlate pronto O'Callaghan Mills, Ireland Presencial
● Nuevo 👁 Visto ✓ Postulado hace 18h
Danaher
Engineering Manager (Verification & Validation)
Danaher
⚡ Postúlate pronto Bangalore, Karnataka, India Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d
Danaher
National Sales Manager India & South Asia ( Location - Bangalore)
Danaher
⚡ Postúlate pronto Bangalore, Karnataka, India Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d
Danaher
Senior Channel Partner (CP) Sales Rep_Thailand
Danaher
⚡ Postúlate pronto Yala, Thailand Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d
Danaher
QA Batch Release Officer
Danaher
⚡ Postúlate pronto Medemblik, Netherlands Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d
Danaher
Production technician
Danaher
⚡ Postúlate pronto Suzhou, Jiangsu, China Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d
Danaher
Senior Sales Representative
Danaher
⚡ Postúlate pronto Tokyo, Japan Presencial
● Nuevo 👁 Visto ✓ Postulado hace 1d

Regístrate para recibir sugerencias adaptadas a los empleos que abres y las búsquedas que guardas.

Más empleos en Danaher

Ver todos los empleos en Danaher →

Postúlate ahora
🤖

Un momento — para

JobsRadar se creó para personas reales que están pasando un mal momento en su búsqueda de empleo — no para solicitudes automatizadas. Estás haciendo clic demasiado rápido y ahora estás bloqueado temporalmente.

Vuelve más tarde. Si de verdad estás buscando empleo, cuentas con nosotros — solo compórtate como una persona.

Catch your next role the second it’s posted.

Create a free account and we’ll watch the boards for you — the instant a job matches your search, it lands in your inbox or Telegram. No digging, no refreshing.

Create free account

Free forever · takes 30 seconds · already have one?

Toma ventaja en tu búsqueda de empleo.

Únete a nuestro canal de Telegram para lo que te ayuda a conseguir el puesto — referencias salariales, el pulso semanal del mercado y avisos de nuevas funciones. Sin spam, solo señal.

Únete al canal — es gratis