Ansell
Regulatory Affairs Manager Americas-PPE - (Job Number: 30005802)
This job is now closed
Job Description
- Req#: 88532
- 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
- Lead designation Strategic Business Unit, functional and/or factory initiatives on high impact cross-functional projects requiring RA expertise linked to the Americas market.
- Management representative for regulatory agency, NFPA, and with certification test houses.
- Plan, coordinate, and organize simultaneous regulatory duties and tasks, including special projects. As they arise, resolve specific administrative and process issues pertaining to regulatory affairs in Americas as required.
- Responsible for NFPA testing and certification for Body protection range.
- Coordinate ASTM overall testing and certification for electricians’ gloves sold in North America.
- Keep abreast of new and revised PPE and environmental regulations, including chemical restriction regulations such as Prop 65 or TSCA as well as FDA indirect Food Regulations; and ensure that these changes are communicated and incorporated into Ansell’s procedures and documents, as well as Ansell PPE products.
- Follow up evolutions on ANSI PPE standards and compliance.
- Perform lobbying towards a more structured and strict PPE regulations within Americas.
- Responsible for the review, critique and/or approval of all proposed labelling copy for all PPE products sold in Americas to assure compliance with relevant Regulations and international standard requirements.
- Answer Regulatory technical inquiries from internal and external customers as required by the parties.
- Conduct regulatory training on PPE Americas standards & regulations as appropriate for new and existing employees as requested.
- Manages the RA specialist teams in Latin America in the preparation and maintenance of technical files, certification for any applicable local regulations for PPE.
- Manage and actively contribute to the professional development of direct reports in accordance with Ansell Policies and procedures.
- Support the Director Regulatory Affairs in the daily functions and the regional projects, and working on tasks and projects as assigned
- Other relevant Regulatory Duties, as required
- BS in Regulatory, Scientific, or technical discipline or equivalent combination of training and experience.
- 5+ years’ experience in Regulatory Affairs, specifically related to PPE, and demonstrated leadership in working with local health authorities.
- Working knowledge of Americas and PPE Regulations.
- Good understanding of NFPA organization and BP testing methods.
- Knowledge in electrical equipment ASTM testing.
- Understanding of ANSI PPE standards.
- Knowledge in environmental local regulations.
- Ability to Travel – 15%
!*!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?
Ansell is looking for a PPE Regulatory Affairs Manager, Americas to join our team in Iselin, NJ!
Specific responsibilities include:
Expert contributor regarding device regulations, standards, and applications for the Regulatory Affairs PPE team. Ensure all company products comply with the applicable regulations in Americas Market for PPE products and are fully compliant where needed, duly certified, prior to distribution. Responsible for compilation, maintenance, approval and submission of all technical files and associated RA documentation in accordance with local regulations. Provide Regulatory support to Ansell’s product development teams and manufacturing plans as required to ensure local regulatory compliance of the PPE sold by Ansell Healthcare.
What would this role look like in detail?
What will you bring to Ansell?
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.
Iselin, Metropark (Remote) (1137450)
111 Wood Avenue South
Iselin, 08830- Competitive compensation plan, base salary, and annual incentive
About the company
Ansell is an Australian company which manufactures protective industrial and medical gloves.