Senior Regulatory Specialist

Job description

Work Flexibility: Hybrid What you will do- · Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan. · Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications in accordance with local regulatory requirements. · Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes and determine required regulatory actions. · Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance with applicable regulations and market requirements. · Coordinate with regional regulatory teams, distributors, and in-country representatives to support regulatory submissions and market access activities. · Monitor regulatory commitments, submission timelines, approval status, and renewal requirements to ensure uninterrupted product availability. · Review technical documentation, product information, labelling, and other supporting records for completeness, accuracy, and regulatory compliance. · Support post-market regulatory activities, including field actions, vigilance-related submissions, product updates, and compliance requests as required. · Maintain regulatory records, databases, and document repositories in accordance with internal procedures and document control requirements. · Track changing regulatory requirements within assigned markets and assess the impact on existing products and planned product launches. · Collaborate with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain teams to obtain required documentation and support regulatory deliverables. · Independently manage multiple projects and priorities while delivering high-quality regulatory outputs within established timelines. · Identify opportunities for process improvements, standardization, and efficiency enhancement across APAC regulatory activities. · Support internal and external audits, inspections, and compliance assessments by providing regulatory documentation and subject matter expertise. · Proactively communicate project risks, regulatory concerns, and potential market access impacts to stakeholders and management. What you will need: Required Skills- · Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline. · Experience - 5 years- 7 years and relevant 3 years of experience in Regulatory Affairs within the medical device, healthcare, pharmaceutical, or life sciences industry. · Experience supporting product registrations, renewals, amendments, and lifecycle management activities across APAC markets; supporting NPI and sustaining engineering activities from a regulatory perspective; working with regulatory information management systems, PLM systems, document control systems, or equivalent tools is preferred. · Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan, or other international medical device markets. · Familiarity with technical documentation, design control, change control, and product lifecycle management processes. · Strong understanding of global regulatory frameworks and quality management principles applicable to medical devices. · Ability to perform regulatory impact assessments and independently determine submission strategies for changes. · Strong analytical, problem-solving, organisational, and project management skills. · Excellent written and verbal communication skills with the ability to collaborate effectively across global teams. · Ability to manage multiple priorities with minimal supervision in a fast-paced environment. Preferred Skills - · Knowledge of ASEAN medical device regulations and international regulatory requirements. · Experience working with distributors, local country representatives, and external regulatory partners; global product portfolios and cross-regional regulatory initiatives. · Familiarity with UDI, product registration databases, and post-market regulatory processes. Travel Percentage: 10%