Regulatory Affair Specialist, Eyewear & Respiratory
Regulatory Affair Specialist, Eyewear & Respiratory
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Why Ansell
At Ansell we stay two steps ahead of workplace risk 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 across industrial medical and consumer applications.
Discover more about our company our people and our values by visiting us at Ansell
Ansell 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 Ansells 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 empoweredacross 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 ( 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 Passion
o Reliable
o Integrity
o Deliver
o Empowerment
Join us to lead the world to a safer future apply today!
Please submit your resume in English.
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
Ansells 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 its 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! Its what drives Ansell as an organization towards a workforce that reflects the communities in which we operate its what drives us to serve our customers and stakeholders with pride and its what differentiates Ansell.
Follow us on Instagram Twitter LinkedIn YouTube and Facebook
Required Experience:
Unclear Seniority
Employment Type
Full-Time
