Regulatory Affairs Specialist / Officer
DiagCor Life Science is the leading biotechnology company specialized in molecular diagnostics (MDx). Over a decade, we have developed innovative MDx products in various fields such as oncology, genetic and infectious diseases. to expand our product pipeline, we are seeking high calibers to join us.
Requirement & Duties
Coordinate and prepare regulatory submission documents (including product technical file) for new and existing products in oversea market.
Compile and maintain regulatory documentation system.
Support and provide project teams on subjects as premarket regulatory requirements, performance evaluation, labelling or clinical study compliance issues throughout a product’s life cycle (from R&D to product launching and PMS).
Participate in internal audits and inspections by National Competent Authority/ Notified Bodies and response to audit finding as required.
Conduct risk management activity to ensure compliance with required statutory and regulatory requirements.
Review product labelling specification and external documents such as IFU, Service Manual or Marketing Materials for compliance with applicable regulations and policies.
Analyze and handling product complaints and post-marketing activities.
Qualification and Requirements
Degree holder or Postgraduate in life science, biotechnology or related discipline;
Minimum 3 years of experience of CE marking in a related field (IVD/Medical device/Health Care Products);
Solid experience in Risk Management and Post-Marketing Surveillance;
Familiarity with ISO 13485 / EU IVDD or a related regulations standard;
Knowledge in molecular biology / clinical evaluation is preferred;
Experience in NMPA / FDA / GMP is an advantage;
Proficient in detailed technical writing, analysis and appraisal;
Strong communication and interpersonal skills;
Team player attitude, proactive and self-motivated.
Proficiency in spoken English & Chinese including Mandarin
Benefits & Others
Dental insurance, Double pay, Education allowance, Five-day work week, Free shuttle bus, Medical insurance, Performance bonus, Travel allowance
For more info, please visit our web page at http://www.diagcorlifescience.com/