Job Responsibilities:
- Execute all regulatory activities including submission of new products or renewals until post-approval monitoring.
- Understand the context of MDD/MDR, ISO 13485, AMDR, 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.
- 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 approval and product registration for worldwide markets.
- Support change notification projects of Critical Care Products (Class IIa 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 in Asia, Europe, and American markets.
- Provide support to QA department for ISO 13485:2016 QMS update based on the Post-market surveillance analysis and trending.
- 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.
- Drive product registration and license renewal activities of Global Markets.
- Register all products models and UDI in EUDAMED database and other country specific product registration database.
Job Requirements:
- Bachelor’s Degree in Pharmacy, Biomedical Science, or equivalent discipline.
- At least 2 years of experience in medical devices/pharmaceuticals industries or related RA experience.
- Knowledgeable in ISO 13485, MDD/MDR, product registration and CE marking is advantageous.
- Strong written and oral communication, and technical writing skill in both English and Chinese to liaise with China stakeholders.
- Knowledgeable in FMEA, ISO 14971, Statistical Process Control (SPC), Problem solving tools, Auditing and Supplier Management skill is preferable.
- Knowledgeable in Medical Device Regulation in countries outside APAC (E.g. USA, EU) is advantageous.
- Able to recommend critical decisions with calculated and justifiable risk through analytical thinking.
- Excellent organization skills, attention to details, and ability to learn fast and handle complex projects and issues.
- Excellent interpersonal and communication skill and possess positive attributes.
- High level of integrity and able to work under stress and deliver work as per scheduled.
- Good communication and interpersonal skills to build cross function and support.
- Self-starter and independent.
Please send your resume in MS WORD to [email protected] indicating your current and expected salary.
We regret that only shortlisted candidates will be notified.
