Regulatory Affairs Executive

3 days ago

Singapore BIOPTIMAL INTERNATIONAL PTE. LTD. Full time

**Job description**:
**Responsibilities**

1. Execute all regulatory activities including submission of new products or renewals until post-approval monitoring.
2. Understand the context of MDD/MDR, ISO 13485, AMDR, FDA 21 CFR Part 820, and other applicable regulations in the markets we served.
3. Compilation, review, coordination, submission, monitoring, follow up of regulatory submissions to ensure expedited processing in accordance with company timelines and targets.
4. Advise internal stakeholders & departments on regulatory guidelines, and regulatory news and updates.
5. Ensure that regulatory activities are complying to internal SOPs and regulatory requirements.
6. Good understanding of the regulatory guidelines/regulations to successfully compile, submit and maintain the technical dossier according to regulatory requirements.
7. Responsible for the regulatory approval and product registration for worldwide markets.
8. 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.
9. Participate in USFDA 510K submission activities and follow up with internal teams by evaluating documentation requirements.
10. Work closely with regional sales team and distributors to drive new registration / license renewal activities in Asia, Europe, and American markets.
11. Provide support to QA department for ISO 13485:2016 QMS update based on the Post-market surveillance analysis and trending.
12. 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.
13. Drive product registration and license renewal activities of Global Markets.
14. Register all products models and UDI in EUDAMED database and other country specific product registration database.
**Requirements**:
1. Bachelor’s Degree in Pharmacy, Biomedical Science, or equivalent discipline.
2. At least 2 years of experience in medical devices/pharmaceuticals industries or related RA experience.
3. Knowledgeable in ISO 13485, MDD/MDR, product registration and CE marking is advantageous.
4. Strong written and oral communication, and technical writing skill in both English and Chinese to liaise with China stakeholders.
5. Knowledgeable in FMEA, ISO 14971, Statistical Process Control (SPC), Problem solving tools, Auditing and Supplier Management skill is preferable.
6. Knowledgeable in Medical Device Regulation in countries outside APAC (E.g. USA, EU) is advantageous.
7. Able to recommend critical decisions with calculated and justifiable risk through analytical thinking.
8. Excellent organization skills, attention to details, and ability to learn fast and handle complex projects and issues.
9. Excellent interpersonal and communication skill and possess positive attributes.
10. High level of integrity and able to work under stress and deliver work as per scheduled.
11. Good communication and interpersonal skills to build cross function and support.
12. Self-starter and independent.

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