Regulatory Affairs Associate Specialist

Why Ansell

At Ansell by staying two steps ahead of workplace risk we aim to deliver innovative safety solutions that enhance peoples quality of life. As a global leader in protection solutions we design and develop a wide range of products including gloves clothing and other protective gear to keep workers safe and productive in industrial medical and consumer applications.

Discover more about our company our team and our values by visiting us at .

Ansell is looking for a Regulatory Affairs Associate Specialist EMEA to join our team in Krakow Poland.

In this position you will support the development of technical files for submission to competent authorities ensuring regulatory certifications for Ansells eyewear and respiratory product portfolio within the EMEA region. Additionally you will act as a back-up for the certification process of Body Protection products and collaborate with Regulatory Affairs teams globally to assist in executing PPE certification processes.

What benefits and opportunities does Ansell offer

• Competitive compensation including a performance-based annual incentives.
• Flexible and hybrid schedule.
• An inclusive and collaborative environment that values diversity and fosters an international culture.
• Ansell University programs to develop professional and interpersonal skills.
• Opportunities to advance and grow within the company.
• Internet allowances car wash allowances pension & disability plan.

What your role will be

As a Regulatory Affairs Specialist EMEA you will:

• Assist in preparation and maintenance of technical files for PPE compliance certifications under supervision of RA Senior Specialist.
  
• Act as back-up for the Regulatory Specialist Body Protection in ensuring regulatory submissions and certification.
  
• Support accurate and timely submissions by gathering required documents from internal departments.
  
• Provide administrative support during Module D audits and Post Market Surveillance activities.
  
• Assist in coordination with Notified Bodies for product testing as directed.
  
• Update regulatory databases and systems ( AssetBank OneLink) as required.
  
• Support preparation of regulatory input for product markings user instructions and marketing materials.
  
• Assist in preparing materials for regulatory induction trainings.
  
• Collaborate with RA teams globally by sharing documentation when needed.
  
• Perform other regulatory support tasks as assigned.

What will you bring to Ansell

• Bachelors degree in a relevant scientific or technical field (e.g. Pharmacy Chemistry Chemical Engineering).
  
• Preferably a first experience in Regulatory Affairs and/or a Quality or Technical function; other relevant experience and specialized training will also be considered.
  
• Understanding of PPE regulations applicable to Ansells business.
  
• Familiarity with PPE regulatory systems across global markets.
  
• Knowledge of product standards and compliance requirements.
  
• Exposure to Quality Assurance methodologies.
  
• Strong PC literacy and proficiency in common software tools.
  
• Positive flexible and can-do attitude.
  
• Strong collaboration and teamwork skills when working with key partners.
  
• Problem-solving mindset to support regulatory compliance.
  
• Effective communication and interpersonal skills.
  
• Results-oriented approach and ability to deliver on commitments.
  
• Strong alignment with Ansell values. Whatever you do take PRIDE:
  • Passion
  • Reliable
  • Integrity
  • Deliver
  • Empowerment

Join us to lead the world to a safer future apply today!

Please submit your resume in English.

Equal Opportunity Employer

Ansell commits to securing an equal opportunity recruitment and selection process. All interested candidates are encouraged to apply and will receive consideration for employment regardless of age sex gender identity sexual orientation race color ethnic origin religion disability genetic information or any other factors that could be deemed discriminatory.

Our Commitment to Diversity Equity and Inclusion

Ansells vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality. When we say that everyone deserves to belong feel included and empowered at work its not just words. Rather its what drives Ansell as an organization towards a workforce that reflects the diversity of our community its what drives us to serve our customers and stakeholders with pride and its also what differentiates Ansell. We believe everyone no matter how that person self identifies deserves an opportunity to achieve success.

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