You are here
Regulatory Affairs Manager - Life Science MNC
- Regional responsibility for Regulatory Affairs activities
- Manage a team of 3 regulatory professionals
About Our Client
My client is a leading global Life Science company with a large operation in Singapore. Through innovative design and precision manufacturing they deliver world class instruments which allow their customers to discover new ways to improve our well being and environment.
You will manage a team of 3 and be responsible for all Regulatory Affairs activities for both my client's Singapore Manufacturer and their ASEAN Business.
- Ensure that the Organisation 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 organisation.
- Provide regulatory training to site staff, FSE/FAS, including QSR, local regulations, etc..
- Review labelling 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 organisation.
- 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 organisation; participate in management reviews
- Post market surveillance, reporting adverse events/recalls to the Authority; review labelling 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 organisational leader
The Successful Applicant
- University Degree in Science / Life science or Engineering (Master Degree is desirable)
- Experience in product local and regional regulatory submissions / registrations
- Knowledge and experience in regulatory requirements : FDA 21cfr part 820 , EU CE IVDD, ISO 9001 / 13485
What's on Offer
A great opportunity to make difference with excellent progression and compensation