• Job Description

  Req#: JR - 123335

  This is where you save and sustain lives

  At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

  Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

  Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

  Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

  For our Country Quality Assurance & Regulatory Affairs Team , we are currently hiring a

  Specialist (f/m/d) Regulatory Affairs for the DACH-cluster

  based in Vienna (hybrid option).

  Your Role at Baxter:

  The Specialist (f/m/d) RA is part of the DACH CQA and RA organization and is responsible to ensure that the following processes are maintained in Germany, Austria and Switzerland (where applicable).

  • Support of regulatory strategies, obtaining and maintaining of marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products.
  • Ensure compliance to regulations (Baxter Corporate Quality Manual, EN ISO 9001, EN ISO 13485, GMP, GDP and country specific requirements)
  • Ensuring contact with Competent Authorities.
  • Ensuring that appropriate contacts with other support functions like Pharmacovigilance, W&D, Technical Service, Businesses and Distributors are maintained.
  • Ensuring that processes and procedures related to the Falsified Medicines Directive (FMD) are in place locally.
  • Support Corporate Quality Systems implementation including local requirements to CQA and distribution.

  Your Responsibilities:

  Specific to RA role:

  • Adapt files to national requirements and/or prepare local registration files for new products.
  • Submit files to national Authorities and monitor their progress, act as contact person with the local MoH.
  • Respond to questions and deficiency notices in cooperation with the Global Regulatory Lead (GRL).
  • Maintain licenses current by submitting renewals at appropriate time.
  • Update files for changes (variations) in cooperation with the GRL.
  • Perform the in-country tasks related to mutual recognition, decentralized and centralized procedures.
  • Ensure regular update of the list of drug licensing status and renewals in the appropriate database.
  • Supervise the obtaining of MOH-approvals to perform clinical studies for medicinal products and medical devices in the respective country.
  • Communicate promptly national requirements to the appropriate persons and inform them about upcoming changes.

  Support of CQA:

  • QA Warehousing & Distribution including RP/QP role (GDP)
  • Post Market Surveillance Local including MOH relationship
  • Internal & External audits management
  • Handling of Non Conformities, CAPAs and Change Controls

  Your Profile:

  • Bachelor's degree in: Pharma, Chemistry, Biology, Natural Science, Medicine or similar degree in scientific fields
  • Minimum 3 years’ experience in CQA/RA in the Pharma/MedTech sector
  • Ability of understanding country specific regulations and general quality and regulatory requirements
  • Ability to liaise with different functions involved (e.g. W&D, TS, PV) andwith multicultural teams
  • Fluency in German and English (spoken and written)
  • Good interpersonal and communication skills
  • People/Project management skills
  • Self-motivation and commitments
  • Computer skills (Word, Excel, Power Point, Outlook, corporate software)

  The remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is 45.500 ,-- euros based on full-time employment. Any corresponding overpayment depends on relevant professional experience and/or qualifications.

  Have we sparked your interest?

  If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System. For further information, please reach out to teresa_feilhuber@baxter.com . We look forward to getting to know you.

  Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

  #IND-DACH

  Reasonable Accommodations
  
  Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

  Recruitment Fraud Notice
  
  Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

• About the company

  Baxter International Inc. is an American multinational health care company with headquarters in Deerfield, Illinois.

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