Regulatory Affairs Manager
Job ID :
Singapore - Marsiling
Take overall responsibilities of Regulatory Affairs for LSG Singapore manufacturer and LSG ASEAN business.
- Ensure that the Organization is in compliance with required Medical Device and IVD regulations; Develop regulatory strategies for NPIs and product registration maps.
- Site regulatory support – develop regulatory procedures, corporate and external audits, authority inspections, labels and docs review and approval; complaint investigation, regulatory knowledge sharing with the staff; AO import permits and goods customs clearance support. Build rapport with regulatory agencies and notified bodies as required, to perform effective and fast approvals for product registrations.
- Work closely with NPI Team to provide regulatory guidance for new product launch and registering them in various markets.
- Be responsible for product registrations and regulatory inspections/3rd party audits; act as a site regulatory lead by supporting QMS and ASEAN business.
- Monitor the regulatory development and trends in the region and report impact to the organization.
- Provide regulatory training to site staff, FSE/FAS, including QSR, local regulations, etc..
- Review labeling and promotional materials for regulatory compliance.
- Build rapport with regulatory authorities, RA counterparts within LT and external partners; Monitor the regulatory development and trends in the region and report impact to the organization.
- Ensure the business compliance with regional / global regulations / requirements; including FDA, HSA , CE IVD and advise management to take key business decisions keeping in view of local regulations and impact to the organization; participate in management reviews
- Post market surveillance, reporting adverse events/recalls to the Authority; review labeling and promotional materials for regulatory compliance
- Provide regulatory strategies/ registration support for registering Food Safety instruments, Animal Health (Veterinary diagnostics) within SEA region LSG SEA RA organizational leader