Job Description & Responsibilities:
- Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
- Develop QMS documents in line with business activity of DxD Hub.
- Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
- Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
- Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
- Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
- Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
- Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
- Ensure that regulatory records are controlled and maintained.
- Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.
Job Requirements:
- Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
- Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
- Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
- Competent in quality assurance methodologies.
- Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
- Demonstrated skills in risk management (ISO 14971).
- Knowledge of Health Sciences Authority requirement for IVD product submission.
- Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
- Experience with product registration submission and evaluation.
- Experience with maintaining internal regulatory database.
- Experience with Dossier Creation.
- Ability to develop and implement plans for regulatory submission.
- Awareness of applicable workplace environment, health and safety regulations.
- Ability to network and build strategic partnership with good problem solving skills and communication skills.
- Possess leadership and agile mindset.
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
