Regulatory Affairs Analyst

Why Ansell?

Ansell is a leading global provider of protection solutions designed, developed, and manufactured to meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives. Driven by passion and ambition, we have developed a comprehensive strategy to change our business and build a more sustainable future. We have declared sustainability as the foundation of a new purpose fully integrated into our business strategy at Ansell: Thinking of People and Planet First. Ansell's vision is heavily focused on Diversity, Equity, and Inclusion to create safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality. Ansell's purpose is protection in every way! Come join a trusted market leader!

What will you get from Ansell?

• Competitive compensation plan, base salary, and annual incentive
• Health Benefits:  medical, dental, vision, short term and long- term disability and wellness programs
• 401-k plan with company match
• Paid time off (vacation, sick and personal days) 12 paid holidays
• Continuing Education Reimbursement
• Flexible and hybrid work model
• Summer Friday's
• Regional Diversity, Equity & Inclusion committees
• Green office concept
• Collaborative and Innovative work environment   

Ansell is looking for a Regulatory Affairs Analyst to join our team in Reno, NV or Iselin, NJ!

About this opportunity: Support in the development and management of regulatory dossiers for submission to the Regulatory Authorities to ensure regulatory certifications for the Americas Region.

What would this role look like in detail?

• Preparation and maintenance of regulatory submission dossiers for US and
• Ensure accurate, complete, and timely submissions to regulatory agencies.
• Liaise with Regulatory Authorities for any follow up requirements regarding regulatory submissions.
• Assist with regulatory authority visits and external notified body audits.
• Monitor compliance by maintaining and updating relevant US FDA databases, Health Canada Medical Device Licenses and Medical Device Establishment License Filings.  
• Post Market Surveillance: Facilitate import/export regulatory activities for Ansell Products to ensure compliance with government regulations as well as coordinate recalls and detentions as required.
• Work in collaboration with Product Management, R&D, Legal and QARA management teams to facilitate appropriate regulatory actions throughout the product life cycle
• Provide Customer support for regulatory related information including compliance or clearance related information.

What will you bring to Ansell?

• Associates or Bachelors' Degree in a relevant scientific/technical field.
• Experience in a Regulatory Affairs Environment within pharmaceutical, cosmetics or medical device.
• Exposure to Quality Assurance methodologies.

Our Commitment to Diversity Equity and Inclusion: 

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 are sensitive and thoughtful and provide 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 diversity of our community, it's what drives us to serve our customers and stakeholders with pride, and it's also what differentiates Ansell. We believe everyone, no matter how that person self-identifies, deserves an opportunity to achieve success.

Ansell's Mission to Sustainability:

Safety culture is what we believe in! Protecting people and Protecting the planet through innovation and sustainability is what we are passionate about. We pledge to minimize use of packaging materials and facilitate effective disposal by making them 100% recyclable, reusable or compostable by 2026. We have set impressive sustainability targets for our operations, including zero waste to landfill from manufacturing facilities by year-end 2023. We are renewing our water stewardship strategies and committing to a 35% reduction in absolute water withdrawals across our plants by fiscal year 2025. We are committed to achieving Net Zero within our operations by 2040. This is supported by a mid-term target to reduce our operational emissions by 42% by 2030. Among the founding members of Responsible Glove Alliance (RGA), we are devoted to improving labor standards alongside our partners. Ansell's long-term decarbonization strategy focuses on shifting to renewable energy sources, product and business model innovation, and reduced reliance on synthetic raw materials. 

Thinking of people and planet first, we strive to ensure the safety of our environment and the safety of the people with whom we share this planet!

Equal Opportunity Employer:

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, gender identity, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, marital 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.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Ansell. Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process.