Regulatory Affairs Specialist

Position Title: Regulatory Affairs Specialist

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.

Attributes:

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.

Qualifications:

Minimum of 2 years regulatory or equivalent experience within the medical device or pharmaceutical company or similar organization.