Our client
Our client is a fast growing medical devices MNC with a strong product portfolio
- Assist in providing regulatory input and technical guidance to global RA team on product regulatory requirements in the assigned markets throughout the product lifecycle
- Coordinate and support the development of optimum regulatory submission strategy for the assigned projects in collaboration with the respective global team and regional commercial partners including distributors; and update strategy based upon regulatory changes
- Coordinate, execute and support the planned regulatory submissions with the respective stakeholders
- Manage the preparation and if necessary submission of regulatory submission package to the respective health authorities
- Assist in identifying and communicating issues early in the submission preparation stage that could impact product launch to the relevant stakeholders
- Work closely and efficiently with global RAQA team to provide appropriate responses to the health authorities queries during the evaluation process
- Close follow up with the respective health authorities during the evaluation process to ensure timely regulatory approvals
- Assist to review and recommend risk-based solutions on special marketing authorization routes with appropriate regulatory agencies to pursue approvals based on special needs
- Coordinate product post marketing approval requirements to ensure that compliance is in placed at all time
- Coordinate post marketing surveillance activities such as FSCA, product recalls, adverse event reporting, etc.
- Regularly and timely update internal stakeholders on projects status and product approvals
- Assist in product regulatory due diligence
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions with other members of regulatory and related teams
- Review and approve labelling and product promotional materials to ensure compliance with regulations and company policy
- Review and submit change controls to assess the impact of change and consequent regulatory submission requirements
- Keep abreast with current and latest regulations in the region; with the guidance from Manager to provide assessment on impact of new, existing and pending regulations, guidelines or standards to internal stakeholders timely
- Develop and maintain Singapore’s office quality related documented procedure for compliance with SS620
- Organize and conduct QMS audits and management review in accordance with the applicable management system and the respective global procedures.
- Provide training for stakeholders on current and new regulatory requirements; regulatory and quality SOPs; and/or working procedures to ensure companywide compliance
- Compile and provide regulatory documents to commercial team and/or distributors in support of tender applications within the region
- Assist and participate as appropriate in regulatory inspections and quality audits
What you should do now
Apply to this job ad or send your CV across to me at [email protected] for a confidential discussion. (Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)
