REGULATORY AFFAIRS EXECUTIVE

Job Responsibilities:

• Execute all regulatory activities including submission of new products or renewals until post-approval monitoring

• Understand the context of EU MDD/MDR, ISO 13485, Australian and Canadian MDR, FDA 21 CFR Part 820, and other applicable regulations in the markets we served.

• Compilation, review, coordination, submission, monitoring, follow up of regulatory submissions to ensure expedited processing in accordance with company timelines and targets.

• Advise internal stakeholders & departments on regulatory guidelines, and regulatory news and updates.

• Provide regulatory requirement guide to internal teams for different countries submission.

• Ensure that regulatory activities are complying to internal SOPs and regulatory requirements.

• Good understanding of the regulatory guidelines/regulations to successfully compile, submit and maintain the technical dossier according to regulatory requirements.

• Responsible for the regulatory approvals and product registration worldwide.

• Support change notification projects of Critical Care Products (Class II and Class III): Follow up with engineering team from manufacturing site on the document requirements for changes submission of EU CE mark, Singapore HSA and other country competent authorities.

• Participate in USFDA 510K submission activities and follow up with internal teams by evaluating documentation requirements.

• Work closely with regional sales team and distributors to drive new registration / license renewal activities worldwide.

• Provide support to QA department for ISO 13485:2016 QMS documentation and update based on the Post-market surveillance and vigilance activities (e.g., PMS Report, PSUR, MIR, FSCA, FSN, USFDA eMDR).

• Create, update and maintain all RA related SOPs, Work Instructions, Forms and Templates in compliance with GMP, ISO 13485, MDD/MDR and other country regulations.

• Register all products models and UDIs in EUDAMED, SWISSDAMED, GS1, GUDID database and other country specific product registration databases.
  

Job Requirements:

• Degree in Biomedical, Pharmaceutical or any science related field.

• At t least 2 years working experience in regulatory requirements compliance and product registrations across APAC, Americas, Middle East and/or Europe (EU and EEA)

• At least 2 years working experience in medical device or IVD post-market surveillance and vigilance including reports creation and reporting to competent authorities.

• Knowledgeable in applicable international standards and common specifications related to the product – ISO 13485, ISO 14971, FMEA, EU MDD/MDR and CE marking is preferred.

• Strong written and oral communications, and technical writing skills in both English and Chinese to liaise with China and international stakeholders.

• Certified in ISO 13485 and MDR 2017/745 is highly advantageous.

• Able to recommend critical decisions with calculated and justifiable risk through analytical thinking.

• Good organization skills, attention to details, and ability to learn fast and handle complex projects and issues.

• Good interpersonal and communication skills and possess positive thinking.

• High level of integrity and able to work under stress and deliver work as per scheduled.

• Self-starter and independent.