Senior Engineer/Engineer QARA (QMS/RA)
Responsible for Quality Management System, Document Control, Change Control, Quality Audits and Training Management. Responsible to review customer-facing documents including product communications and software release notes.
To work on Regulatory Product Registrations in APAC and EU. This job requires close interactions with R&D partners for STED file preparations and with Regulatory Authorities / Business partners for registrations.
Duties & Responsibilities
- Responsible for Document control and Change Control, including software releases
- Responsible for training management system in collaboration with HR
- Conduct Internal Quality Audits and manage external audits / inspections
- Review customer facing documentations including product communications
- Manage post market activities such as health hazard evaluation, medical device reporting and recall documentation
- Work on product registrations in APAC (including ANZ ) and EU countries
- Prepare Product Technical Documentation File/ Common Submission Dossiers for regulatory submissions
- Liaise with Regulatory Authorities in regulatory submissions, analysis and submission of change notifications and provide timely response to input requests
- Work with Product Managers / Marketing on Regulatory strategy for submissions
Job Requirements & Attributes
a. Degree or Post Grad in Life Sciences or BioEngineering
b. Min 3 years experience in medical device or pharma will be an advantage
c. Experience in ISO 13485 environment. GMP knowledge will be an advantage
d. Work well with others to deliver results
e. Technically competent (product/process knowledge). Hands on person.
f. Communication and presentation skills will be a strong advantage
g. Good Quality Systems mindset. Good documentation skills and attention to detail
h. Eager to learn and like challenges
Interested applicants are invited to submit your resume with a recent photo, indicating your current and expected salary to email@example.com
We regret only shortlisted candidates will be notified.