Regulatory Affairs Specialist, Body Protection
Located in Krakow, PL.
Ansell is a global leader in protection solutions. We design and develop gloves, clothing, and other protective gear to keep workers safe across industrial, medical, and consumer applications.
Why Ansell?
At Ansell we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people’s quality of life. Joining our team means contributing to safer products for workers worldwide.
Benefits and Opportunities
- Competitive compensation, including performance-based annual incentives.
- Flexible and hybrid schedule.
- A culture of belonging, inclusion and collaboration.
- Ansell University programs for professional development.
- Opportunities to advance and grow within the company.
- Employee perks: cafeteria system, my benefit, multisport card, medical insurance.
Role Overview
You will support the development of technical files to secure regulatory certifications for Ansell’s Body Protection products in EMEA, and assist global Regulatory Affairs teams in executing the PPE certification process.
Your Responsibilities
- Prepare and maintain technical files for European PPE (Body Protection) certifications.
- Support accurate and timely submissions to regulatory agencies and Notified/Approved Bodies.
- Coordinate with departments to collect required documentation.
- Liaise with Notified/Approved Bodies for product and Module C2 testing; assist with Module D audits.
- Monitor compliance by initiating internal and external product lab tests.
- Conduct post-market surveillance activities.
- Collaborate with Marketing on product markings and user instructions.
- Keep the Regulatory Affairs team informed of relevant updates and business impacts.
- Support regulatory induction training for new employees.
- Review and approve marketing materials and internal product specifications.
- Provide regulatory support to regional teams (APAC, NA, LAC, Middle East) for PPE certifications.
- Maintain global PPE regulatory databases and platforms (e.g., Ansell.com, AssetBank, OneLink).
What You’ll Need
- Scientific or technical background (e.g., pharmacy, chemistry, chemical or textile engineering).
- Experience in Regulatory Affairs, Quality, or Technical roles preferred.
- Understanding of PPE regulations relevant to Ansell’s business.
- Knowledge of global PPE regulatory systems and product standards.
- Exposure to quality assurance methodologies.
- Strong computer literacy.
- Positive, flexible, proactive attitude with strong collaboration skills.
- Problem‑solving mindset to support regulatory compliance.
- Team‑oriented with a results‑driven approach.
- Good communication and interpersonal skills.
- Strong alignment with Ansell values: Passion, Reliability, Integrity, Deliver, Empowerment.
EEO Statement
Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, marital status, parental status or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.
Our Commitment to Belonging and Inclusion
Ansell’s vision is about creating safe spaces where all perspectives are valued alongside individual contributions. We strive to build an inclusive environment that reflects the communities in which we operate.
We look forward to receiving your application in English.