Regulatory Affair Specialist, Eyewear & Respiratory

Kraków, małopolskie
Stała
Pełny etat

6 dni temu

Why Ansell?At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's 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 across industrial, medical, and consumer applications.Discover more about our company, our people, and our values by visiting us atAnsell is looking for a Regulatory Specialist, Eyewear & Respiratory to join our team in Krakow, PL.In this position you will play a vital role in supporting development of technical files and regulatory certifications for Ansell’s EMEA eyewear and respiratory products, provides back-up for Body Protection certifications, and collaborates with global Regulatory Affairs teams on PPE certification processes.What benefits and opportunities does Ansell offer?

Competitive compensation, including a performance-based annual incentives

Flexible and hybrid schedule

A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered—across our global community

Ansell University programs to develop professional and interpersonal skills

Opportunities to advance and grow within the company

We provide cafeteria system, my benefit, multisport card, medical insurance

What your role will be?Collaborating with our cross functional teams, and reporting to the Associate Director EMEA, you will have the opportunity to:· Prepare and maintain technical files for EMEA PPE compliance (Eyewear & Respiratory) in coordination with Associate Director EMEA.· Ensure accurate and timely submissions to regulatory agencies and Notified/Approved Bodies.· Collect and coordinate required documents across departments.· Liaise with Notified/Approved Bodies for product testing, including Module C2, and support Module D audits.· Monitor compliance via internal and external lab testing and conduct Post-Market Surveillance.· Collaborate with Marketing on markings, user instructions, and review/approval of collateral and datasheets.· Provide regulatory input on internal manufacturing product specifications (IPS/PPS).· Support regional RA teams (APAC, NA, LAC, Middle East) with PPE certification processes.· Maintain global PPE regulatory databases and systems (Ansell.com, AssetBank, OneLink, etc.).· Contribute to RA induction trainings and keep RA leadership informed on relevant issues.· Perform other regulatory duties as needed.What will you bring to Ansell?· Previous experience in Regulatory Affairs and/or Quality or Technical function.· Understanding of PPE regulations, product standards, and global regulatory systems· Familiarity with Quality Assurance methodologies· Strong PC literacy· Positive, flexible, and results-oriented mindset· Strong collaboration, teamwork, and communication skills· Problem-solving ability to support regulatory compliance· Strong alignment with Ansell Values:Whatever you do, take PRIDE:o Passiono Reliableo Integrityo Delivero EmpowermentJoin us to lead the world to a safer future, apply today!Please submit your resume in English.EEO StatementAnsell 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 InclusionAnsell’s vision is about creating safe spaces where all perspectives are valued alongside individual contributions.When we say that everyone deserves to belong, feel included and empowered at work, it's not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all, regardless of age, gender, background, disability, veteran status, or experience alone! It’s what drives Ansell as an organization towards a workforce that reflects the communities in which we operate, it’s what drives us to serve our customers and stakeholders with pride, and it’s what differentiates Ansell.Follow us on , , , and

Ansell

Aplikuj