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

Über diese Regulatory Support Specialist (f/d/m) Stelle bei Danaher

Danaher · Vor Ort · 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.

Bereit, sich bei Danaher zu bewerben?
Bei Danaher bewerben

Über 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 .

Alle Jobs bei Danaher ansehen →

Ähnliche Jobs

Danaher
Credit Control Assistant Accountant
Danaher
⚡ Früh bewerben Sydney, New South Wales, Austr... Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Danaher
Freight and Logistics Specialist
Danaher
⚡ Früh bewerben Torrance, California, United S... Vor Ort $80,000–$90,000
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Danaher
Operations Team Lead -Night Shift
Danaher
⚡ Früh bewerben O'Callaghan Mills, Ireland Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Danaher
Engineering Manager (Verification & Validation)
Danaher
⚡ Früh bewerben Bangalore, Karnataka, India Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Danaher
National Sales Manager India & South Asia ( Location - Bangalore)
Danaher
⚡ Früh bewerben Bangalore, Karnataka, India Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Danaher
Senior Channel Partner (CP) Sales Rep_Thailand
Danaher
⚡ Früh bewerben Yala, Thailand Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Danaher
QA Batch Release Officer
Danaher
⚡ Früh bewerben Medemblik, Netherlands Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Danaher
Production technician
Danaher
⚡ Früh bewerben Suzhou, Jiangsu, China Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Danaher
Senior Sales Representative
Danaher
⚡ Früh bewerben Tokyo, Japan Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.

Registrieren für Vorschläge, die auf die von Ihnen geöffneten Jobs und gespeicherten Suchen zugeschnitten sind.

Mehr Jobs bei Danaher

Alle Jobs bei Danaher ansehen →

Jetzt bewerben
🤖

Moment — langsam

JobsRadar wurde für echte Menschen gebaut, die eine schwere Zeit bei der Jobsuche haben — nicht für automatisierte Anfragen. Sie klicken viel zu schnell und sind jetzt vorübergehend blockiert.

Kommen Sie später wieder. Wenn Sie wirklich auf Jobsuche sind, stehen wir hinter Ihnen — verhalten Sie sich einfach wie ein Mensch.

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?

Verschaffe dir einen Vorsprung bei der Jobsuche.

Tritt unserem Telegram-Kanal bei für das, was dir hilft, die Stelle zu bekommen — Gehaltsbenchmarks, den wöchentlichen Marktpuls und neue Feature-Drops. Kein Spam, nur Signal.

Dem Kanal beitreten — kostenlos