Regulatory Affairs Specialist

Why Ansell?

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. The world’s need for better protection never stops, so Ansell is constantly researching, developing and investing to manufacture and distribute cutting edge product innovation and technology, marketed under well-known brands that customers trust. Operating in two main business segments, Industrial and Healthcare, Ansell is the market leader that continues to grow, employing 14,000 people worldwide.

For more information about our Company, our People and our Values, please follow the link https://www.ansell.com

Ansell is looking for Specialist, Regulatory Affairs PPE to be based in Cyberjaya, Malaysia. This position is accountable for the management of regulatory matters and for any compliance activities in the designated geography of SEA.

You will be the contact person for SEA with the relevant stakeholders and authorities, ensuring compliance to all pertinent regulatory rules, working with the authorities in SEA on adaptation of standards and relevant practices. Provides regulatory assessment/advice and reviews packaging & marketing collaterals.

You will play a major role in ensuring that regulatory requirements for Ansell’s products are met, keep up-to-date and communicate new/updated regulatory developments in SEA. Maintain and renew license /certificates to ensure market continuity

This function collaborates and supports regulatory aspect for Ansell’s Medical and PPE related projects in SEA region.

What you can expect from Ansell?

• Work for a world leader in the health and safety protection solutions industry.
• A secure workplace with competitive remuneration and annual bonus based on own and company performance.
• Flexible schedule with a combination of home and office-based working.
• Inclusive, collaborative, and supportive work atmosphere.
• A diverse and international work environment.

What your role will be in details?

Reporting to the Manager, RA SEA, you will:

• Request and coordinate with the respective cross-functional teams to provide all relevant registration requirements
• Compile certification files in accordance with the country specific requirements
• Coordinate required testing submissions with Ansell’s or with independent test houses, when relevant required as per respective local standards
• Fulfill supplementary requirements when requested by authority
• Follow-up and communicate compliance status to stakeholders
• Issues RA Approval notice to stakeholders
• Research and 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.
• Manage marking requirement (e.g. SIRIM-DOSH sticker)
• Maintain and renew license /certificates to ensure market continuity
• Attends regulatory trainings
• Provide RA training internal stakeholders in SEA
• Support regulatory audits at manufacturing sites as required – internal/external
• Support in tender requests if required for regulatory purposes
• Support and maintain RA databases e.g. RA Dashboard, PRT, TrackWise
• Any other duties requested by the RA Manager SEA

What will you bring?

• Bachelor’s degree in medical, pharmaceutical, chemical or engineering.
• 1 to 3 years Regulatory experience
• Knowledge of Medical & PPE Regulations or standards in SEA
• Written and spoken English
• Ability to liaise with a wide range of internal and external stakeholders and partners
• Excellent organization and prioritization skills
• Good communication skills
• PC literate: sufficient knowledge of PC, network and standard package used under Windows
• Travel expected domestically and internationally (up to 30%)