Job Detail

Regulatory Affairs Specialist (m/f/d)

Inseriert am: 19.02.2021
JOB DESCRIPTION

Help us improve access to life-changing therapies that can transform human health


We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.



Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.


What you’ll do



  • Provides regulatory input for product development and R&D teams to ensure compliance to regulatory requirements in target markets.  This includes collaborating with other regulatory teams (Product Regulatory Compliance).

  • Develops regulatory strategies and risk mitigation strategies to guide project teams and R&D to ensure compliance to regulations.

  • Works with cross functional teams to determine project plans and timelines in order to implement changes to product regulatory requirements when regulations or standards change.

  • Assess technical documentation for compliance to regulatory requirements, especially as part of NPI, change controls, or open projects.

  • Contributes to writing and editing technical documentation.

  • Researches, analyzes, integrates and organizes background and/or technical information from diverse sources to support regulatory submissions.Supports regulatory inspections as required.Performs a broad variety of tasks in support of product and process design.


Who you are



  • Bachelor’s degree and a minimum of 3 years work experience.  Minimum of 1 year in regulatory role preferred.  

  • Ability to communication effectively in English (written and oral).

  • Demonstrated experience and proficiency with MS Office word processing, spreadsheets, etc.

  • Minimum of 3 years experience in a regulated industry is preferred.  Advanced degree in scientific, technology or legal disciplines.  

  • Ability to work independently in a fast-paced, compliant environment with little supervision.  

  • Ability to adapt to change and influence positive change effectively.  

  • Team-oriented and responsive to customer needs.  

  • Attention to detail and results oriented.  

  • Ability to understand technical documentation and procedures.


Who we are


Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.


Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!


Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.


Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.


Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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