Regulatory Affairs

We are a global leader in manufacturing of medical devices and deliver solutions to improve lives through today’s technology and future innovation. Due to business needs, we are now seeking for multiple experienced Regulatory Affairs executives to be part of our Regulatory Affairs team for ongoing transformation projects due to expansion.

**Regulatory Affairs Executive**
- Execute all regulatory activities including submission of new products or renewals until post-approval monitoring
- Understand the context of MDR, EN ISO13485, AMDR, FDA 21 CFR Part 820, and applicable regulation 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
- Provide regulatory requirement guide to internal teams for countries submission
- Interface with relevant local and overseas stakeholders to define product profile and successfully translate into clinical development
- Identify the regulatory trend related to clinical aspects and ensure that regulatory activities are complying internal SOP
- Good understanding of the regulatory guidelines/regulations to successfully dossier preparation, submission, and maintenance
- Responsible for the regulatory approval and product registration for local and distributed countries.
- Coordination with internal and external stakeholders to ensure the objectives are met
- 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 CE mark and HSA
- Keep updated with any new rules or changes for local regulation
- Participate in FDA 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 regulatory support to R&D team in strategic planning, pre-marketing, and related submissions to support optimal timelines for new and changed product launches
- Provide support to QA department for ISO 13485:2016 QMS update based on the result of gap analysis of MDD and MDR
- Perform investigation and create documentation for any ad-hoc issues and activities
- Market research of regulatory requirements
- Drive registration and license renewal activities of Global Markets
- Update the company’s QMS documents and records according to new regulatory requirement Update and maintain the company’s technical document
- Design dossier and QMS documentation to comply with regulatory requirements
- Work closely with regional sales team and distributors to drive new registration / license renewal activities in Asia, Europe and American
- Understand the entire process of documentation control to ensure a good filing system with proper documentations of all records is ready for internal and external auditing
- Be an active member in communication and engagement within the team

**Requirements**:

- Bachelor’s Degree in Pharmacy, Biomedical Science, or equivalent discipline.
- At least 1-3 years of relevant working experience in regulatory affairs. Fresh graduates with relevant internship experience are welcome to apply.
- Familiar with ISO:13485, MDR, product registration and CE mark is advantageous
- Strong written and oral communication, and technical writing skill in both English and Chinese to liaise with China stakeholders
- Knowledge of FMEA, Statistical Process Control (SPC), Problem solving tools, Auditing and Supplier Management skill is preferable
- Knowledge of 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