Regulatory Affairs Executive

About the role

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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at BIOPTIMAL INTERNATIONAL PTE. LTD.? Share your experience