Regulatory Affairs Specialist

Regulatory Affairs Specialist

Position Title: Regulatory Affairs Specialist

Reports to: Quality Assurance / Regulatory Affairs Manager

Location: NCR

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.