Job Summary: to coordinate and manage all related RA local activities for the Toxicology portfolio in APAC, Africa and LATAM RA local regional team
Job Scope:
· Support and develop regulatory submission plan for APAC, and Africa regions in collaboration with the RA INT Manager, RA INT team, project team, supply chain or applicable stake holders.
· Shape and support innovative regulatory strategy for new product introduction, pre-market registrations and execute change notification amendment registrations to support product life cycle management as per business needs.
· Evaluate the type of regulatory process applicable per product based on RA proposal and COMM needs.
· Confirm to RA the registration requirements, labeling/translation requirement, and estimated times for each process.
· Work closely with RA INT team and other functions to obtain all the necessary documents to support local country product registration, renewal or amendment to existing product certificates. Review documents provided RA (LoA, CFG, etc)
· Follow up on dossier preparation and additional local procedures
· Coordinate applicable local translations and review them.
· When applicable, submit the Dossier on the electronic system and provide copy of final submission provided to local MoH and proof of submission date to RA
· Ensure timely execution of regulatory strategies as per plan.
· Collaborate with RA INT team to track regulatory milestones in internal Regulatory database.
· Report submission status via defined Key Performance Indicators.
· Reports on the authorization or denial of each regulatory procedure.
· Represents RA locally at relevant in country meetings in collaboration with RA INT team.
· Responsible for review of promotional material for the applicable regions.
· Support strategic Quality and Regulatory Affairs Goals and objectives.
· Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
· Coordinate Legalizations, when applicable
· Ensure warehousing activities to be align with approvals.
· Keep up to date the tracking's and data’s
· Support and collaborate with RA country teams on the surveillance activities
Requirements:
· BSc or equivalent with a minimum of 5 years’ experience in RA in Medical Devices, ideally in IVDs and non-IVD
· Demonstrable working knowledge of the medical diagnostics industry, including non-IVD products.
· Demonstrated capacity in project management.
· Able to navigate in a cross functional environment .
· Knowledge of the regulatory regulations and environment in key countries
· IVD medical device regulations e.g. ASEAN Medical Device Directive, US FDA, EU IVDD/IVDR regulatory environment, legislation, industry standards and guidance and digital health product regulations and requirements.
· Knowledge of ISO 13485 and GDPMD requirements.
· Good written and oral communication skills
· Attention to detail and good interpersonal skill
· Highest levels of integrity and diplomacy
· Capacity to maintain the highest levels of confidentiality internally and externally
Additional Information:
· Contract duration: 12-month contract
· Commencement Date: Immediate
· Working days and hours: Mon to Friday, 9am to 6pm
· Location: Duo Tower, Bugis MRT
