Specialist

Job Description - Specialist, Regulatory OLAC (Colombia y / o México) (30007064)

Job Description

Specialist, Regulatory OLAC (Colombia y / o México)-(30007064)

Description

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that 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.

Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or during their leisure time, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.

GENERAL SUMMARY OF POSITION :

This position reports to the Regulatory Affairs Manager, Americas.

The Specialist, Regulatory Affairs (RA) is accountable for the management of regulatory matters and for any compliance activities in the designated geography of OLAC region (= Latin America except Brazil, Argentina, Mexico, Chile) for Ansell’s PPE products.

The incumbent is the local contact person for PPE product compliance, with the relevant stakeholders and authorities, ensuring compliance to all pertinent regulatory rules, working with the authorities or federations in OLAC region on adaptation of standards and relevant practices. Provides regulatory assessment / advice as part of overall business planning / strategies.

The incumbent plays a major role in ensuring that regulatory requirements for Ansell’s products are met, keep up-to-date and communicate regulation developments in OLAC region, and supports Ansell’s respective Commercial and Industrial teams in deriving business decision. Supports local functional teams and propose feasible regulatory solutions.

This function collaborates and supports regulatory aspect of Regional and Industrial projects in specified geographies. The incumbent shall represent Ansell to participate in relevant regulatory associations in these jurisdictions.

Communicates new / updated regulatory developments and requirements.

This function will also support the Regulatory team for other regions such as Argentina, Mexico and Chile

The scope of the function includes Personal Protective Equipment.

Peer Positions (What other jobs might this job best compare within the Company.)

Regulatory Affairs Specialist (other geographies)

RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES

• Request and coordinate with the respective Ansell functional teams to provide all relevant registration requirements
• Compile certification files in accordance with the country specific requirements
• Coordinate, where required, required testing submissions with Ansell’s or with independent test houses, when relevant required as per local standards
• Fulfill supplementary requirements when requested by authority
• Follow-up and communicate compliance status to stakeholders
• Coordinate with multi-functions (, Manufacturing, QA, Test Centres) on samples requested for testing
• Arrange to ship samples for testing and follow-up on the test results.
• Provide input into Regulatory and Assessment Advice Reports.
• Keep track of the latest regulatory trend, review the impact and communicate to relevant stakeholders following internal processes
• Review and approval of packaging & marketing materials as required in compliance with local regulations
• Attends PPE regulatory trainings
• Participation in PPE federations / standards committees as applicable
• Provide RA Orientation / training to new employees and internal stakeholders in the region
• Support regulatory audits at manufacturing sites as required
• Support in tender requests if required for regulatory purposes
• Any other duties requested by the RA Manager Americas linked with regulatory requirements in the region.
• Work with Marketing to develop the required markings for PPE products.
• Maintenance of the Global PPE Regulatory databases & similar systems used by Global Regulatory such as the website, AssetBank, Trackwise, etc
• Support other RA functions in Mexico / Chile / Argentina
• Other relevant PPE Regulatory Duties, as required

KEY POSITION REQUIREMENTS (what education, knowledge and experience is required at a minimum level to perform the job’s responsibilities.)

Education

Bachelor’s Degree preferably in a relevant field of study , personal protective equipment, medicinal, pharmaceutical, chemical or engineering.

Job Experience

Previous experience in the Personal Protective Equipment sector, Regulatory Affairs, Quality or Technical function is seen as a major advantage.

Knowledge and Skills

Desirable Job Competencies

Additional requirements