Principal Regulatory Affairs Specialist

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Summary

Provides advisory support to marketing, sales, operations and other company stakeholders. Manages regulatory submissions (new and renewals) in compliance with local country requirements and company’s standards. Contributes to day-to-day requests from Sale and Marketing colleagues.

Essential duties and responsibilities

• Supporting EMEA regional business by providing RA support to Marketing, Customer Service & Sales w.r.t queries, assistance in tenders, provision of regulatory documentation etc.

• Planning and coordinating the requirements for compiling technical dossiers as part of regulatory submissions for new product registration and renewal of existing registrations. Communicating all requirements to manufacturing sites and the global Regulatory Affairs team. Tracking and following up in a timely manner to ensure deadlines are met.

• Providing the required support for the company’s distributors in local markets to ensure regulatory compliance with local legislation requirements. Addressing gaps and making plans for any remediation where appropriate.

• Reviewing all technical documentation, product labels, and user instructions to ensure compliance with each country’s regulations.

• Creating and maintaining tracking process and reporting tools for all QA/RA tasks, including registration file submissions, approvals, renewals, projects and tender requests.

• Supporting preparation of Regulatory Submissions for countries in EMEA region. Communicating all requirements to manufacturing sites and global Regulatory Affairs team. 

• Gathering and disseminating regulatory intelligence information that affects regional registrations/compliance.

• Managing regulatory aspect of Product Life Cycle by ensuring updated and obsolete products are handled appropriately internally and externally.

• Advising the business in regulatory requirements.

• Implementing company’s RA framework and tools throughout EMEA region, Emerging Markets business locations.

• Region scope: CE, SEE, CIS, Turkey.

Qualifications, Education and/or experience

• Bachelor’s degree or country equivalent in a scientific discipline.

• English proficiency is a must!

• Ukrainian/Russian proficiency is preferable.

• Minimum of 5 years regulatory or equivalent experience within MEDTECH or /and Pharma (preferred in MedTech) company, or similar organization.

• Skilled in Microsoft Office Suite.

• Strong ability to influence and negotiate at a high level.

What do we offer?

• Fixed-term contract for 3 months and then for an indefinite period.

• Competitive salary, annual bonuses, recognition award program.

• Possibilities for development on a personal and professional level in one of the leading global MedTech companies.

• Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.

• Bax4U - cafeteria/lunch cards (300 PLN).

• PPE program with very attractive conditions available for each employee after 3 months.

• Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA).

• Co-financing of holidays and an additional 2 days off from work annually.

• Day off for birthday!

• Employee Stock Purchase Plan.

• Bax Flex - hybrid model (3 days from the office).

• Extraordinary Warsaw office location - Powiśle!

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is 184 000,00 PLN annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.

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