APAC Senior Regulatory Affairs Specialist (one year contract) Permanent

We’re looking for a candidate to fill this position in an exciting company.

• Support and develop regulatory submission plan for the region in collaboration with project team, manufacturing sites, supply chain, marketing, country manager and Distributor countries;
• Support shape innovative regulatory strategy for new digital diagnostic products
• Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates
• Ensure timely execution of regulatory strategies as per plan
• Track regulatory milestones in internal Regulatory database;
• Report submission status via defined Key Performance Indicators;
• Represents RA and/or APAC at relevant meetings;
• Responsible for review of promotional material for assigned geography location
• Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.

• BSc or equivalent.
• A minimum of 5 years’ experience in Regulatory Affairs in Medical Devices, ideally in IVDs
• Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD)
• Demonstrated capacity in project management
• Able to navigate in a cross functional environment
• Knowledge of the APAC regulatory environment(ASEAN, SAAR countries), including SaMD US FDA and regional digital health regulations and requirements, legislation, industry standards and guidance
• Excellent written and oral communication skills in English
• Attention to detail.
• Strong interpersonal skills.
• Highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality internally and externally.