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.

SUMMARY

Join us on our journey to save and sustain lives in a strong experienced Regulatory Affairs/Country Quality Assurance Nordic team.
In this meaningful role you will work with both medical devices and pharma products.
As a Country Quality Assurance specialist, your main responsibility will be to drive quality work within the marketing companies in the Nordics.
This means, among other things, that you manage our quality system, implement local and global instructions, participate in projects related to the quality area and train colleagues in the Marketing company in quality.
You will also have the possibility to develop and manage some additional RA related tasks.
To thrive in this role, you should be a confident and humble person with the ability to navigate and build strong internal relationships.
The position is based in Kista/Stockholm and you will report to the Manager Regulatory Affairs and Country Quality Assurance Nordics.

QUALIFICATIONS

• Based in Sweden and familiar with GDP requirements and the regulatory environment in all Nordic countries for pharma products and/or medical devices.
• Self-motivation and ability to work in a cross-national and cross-functional matrix organization.
• Skills and personal attributes for international teamwork, dedication to meet both internal and external customer expectations.
• Ability to liaise with different functions involved, Regulatory Affairs, Pharmacovigilance, Customer Service, Supply Chain, Nordic Warehouse, Technical Service and Business.
• Good interpersonal and communication skills
• High work ethics and deep understanding of the quality requirements with medicinal products
• Communicate fluently in Swedish and in English internally and externally.

EDUCATION AND/OR EXPERIENCE

• Bachelor’s/master’s degree or equivalent experience, preferably in Pharmacy, Life sciences or corresponding Chemical engineering.
• Minimum 3 years professional experience of Quality Assurance work in pharmaceutical companies and in quality systems.
• Familiar with the regulatory environment in all Nordic countries.
• Good knowledge in ISO 9001, ISO 13485 standards, EU GDP and Local GDP requirements at Nordic level
• Experience in National Competent Authorities (NCA) communication in Sweden and other Nordic countries.
• Preferred/Advantage: Experience of working in Regulatory affairs, working in a UK/Ireland/Malta/Nordic QA/RA environment, Medical Device and EU Medical Device Regulation.

CQA RELATED TASKS:

• Manage and continuously work to improve our quality system.
• Support the Responsible Person and/ or Qualified Person in areas related to QA and compliance to and with National Regulations.
• Initiate, participate and lead quality-related projects within the Marketing Company.
• Ensure control of approval, distribution, and filing of quality documents.
• Support the implementation of the Quality Manual including monitoring of the performance of the quality system.
• Implement and Manage Nordic Field corrective actions for both medical devices and pharmaceuticals.
• Coordinate Complaint management process in the Nordics.
• Handle non-conformity reports for Marketing Company. CAPA-initiator.
• Ensure that systems and instructions are in place and maintained to train employees in quality system compliance.
• Support business leaders in the assigned countries in quality related matters and inquiries.
• Support Baxter customers´ quality related inquiries.
• Support the Nordic Region audit program for local Quality Management System and Distributor compliance.
• Support in Audits and Inspections (internal/ external) as needed.
• Support the implementation of the Corporate Quality Manual and the applicable ISO 9001 & ISO 13485 standards and GDP requirements at the Nordic level.
• Support in application of the processes and development of procedures related to above mentioned activities.
• Have continuous contacts both with country Regulatory Affairs Specialists as well as Country Regulatory Affairs authorities.
• Act professionally and efficiently to serve customers (internal and external) with high-quality information in a timely manner.

POSSIBLE/POTENTIAL RA TASKS:

Where required, the CQA specialist may have additional responsibilities including but not limited to:

• Working closely with other Nordic and Global RA leads to managing and implementing regulatory strategies for assigned product portfolio and Life Cycle Management Submissions for medicinal products.
• Maintain internal and external product information databases and change controls.
• Handle product information updates, review translations and labelling updates for both pharma and medical devices.