Position Title: Regulatory Affairs Specialist
Reports to: Quality Assurance / Regulatory Affairs Manager
Main Purpose & Key Accountabilities:
- Write, analyse and edit technical documents to support EU MDR submissions. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Assist in preparing response to regulatory authorities’ questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory climate.
- Experience in managing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance will be added advantage.
- Get actively involved in the Technical file preparation of various Class II devices.
- Preparing Post Market Technical file and implementing post market requirement for MDR.
- Strong understanding of Design Control processes including standards like ISO13485:2016, ISO 14971 is must
- Other responsibilities as assigned by reporting manager.
Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills.
Experience and Knowledge:
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
- Proactive, high performance, result oriented and manage projects with ethical integrity
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
- Demonstrate both creative and critical thinking skills.
Minimum of 2 years regulatory or equivalent experience within the medical device or pharmaceutical company or similar organization.