Regulatory Affairs

• Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the U.S. (FDA), EU (IVDR), Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries, ensuring timely approvals and continued market access. 

• Compile, review, and maintain regulatory technical documentation, including technical files, GSPRs, and CERs, to ensure compliance with IVDR and country-specific requirements. 

• Partner with R&D, Quality, and Commercial teams to integrate regulatory requirements into product development, design control, labeling, and change control processes. 

• Ensure company-wide compliance with cGMP and established procedures by collaborating with Quality Systems on adherence to GMP/QSR, ISO 13485, and MDSAP standards. 

• Perform product risk assessments and support evaluation of complaints and non-conformances; assist with investigation and documentation. 

• Manage and support recalls, Medical Device Reporting (MDR), advisory notices, and related post-market regulatory reporting. 

• Provide strategic regulatory guidance on submission planning, global compliance strategies, risk classification, and literature research. 

• Research and interpret global regulations to assess impact and recommend actionable compliance strategies. 

• Manage product registration, listing, and licensing activities, including renewal of business licenses in global markets. 

• Develop and maintain regulatory SOPs, guidelines, templates, and training content; deliver Regulatory Affairs and company-wide regulatory compliance training. 

• Review and approve product labeling, IFUs, user manuals, SDSs, and promotional content for regulatory compliance. 

• Monitor complaint-handling systems and support CAPA management to ensure effective resolution and prevention of recurrence. 

• Track changes in global regulatory requirements and perform gap analyses to ensure continued compliance and proactive remediation. 

• Generate and manage import/export documentation and facilitate customs clearance for product distribution. 

• Lead or support global Post-Market Surveillance (PMS) activities, including complaint trend analysis, vigilance reporting, and preparation of PMS documentation in accordance with IVDR. 

• Develop and execute Post-Market Performance Follow-up (PMPF) plans to gather performance data, literature, and user feedback for integration into CERs and risk management. 

• Contribute to departmental continuous improvement initiatives to enhance process efficiency, regulatory compliance, and documentation quality. 

• Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings. 

• Assess the regulatory impact of product and process changes and contribute to the change control process to ensure timely and compliant implementation. 

• Coordinate with external regulatory consultants or local agents for international submissions; support budgeting and planning activities for regulatory projects. 

• Support R&D throughout the product development process, from concept and feasibility through design, verification/validation, and commercialization, to ensure regulatory requirements are met at every stage. 

• Provide ongoing regulatory support for marketed products, including evaluation of design or process changes, post-market modifications, and lifecycle management activities to maintain global compliance. 

Core Competencies 

• Practical experience in the IVD field, with a solid understanding of regulatory requirements. 

• Knowledge of compliance requirements related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other relevant markets. 

• Familiarity with international standards and regulations applicable to IVD devices, including ISO 13485:2016, ISO 14971:2019, and MDSAP. 

• Strong analytical and problem-solving skills, with the ability to investigate and resolve regulatory issues. 

• Effective interpersonal skills and the ability to collaborate within cross-functional teams. 

• Strong organizational skills, attention to detail, and ability to manage multiple priorities and meet deadlines with some guidance. 

• Clear oral and written communication skills appropriate for internal and external stakeholders. 

• Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS.