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- Creating and reviewing regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals.
- Interacting with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals.
- Tracking status and progress of regulatory documentation that will be used for renewals.
- Coordinating and compiling responses to regulatory authority renewal questions (under supervision)
- Using an electronic document management system to compile documents to support product renewals for submission to Health Authorities
- Answering internal queries for assigned products.
- Maintaining Database of Regulatory Requirements for renewals
Skill-sets and Requirements - Regulatory experience within a healthcare environment, specifically Medical Devices
- Administrative and project management skills
- Ability to contribute to multiple projects from a regulatory affair perspective
- Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research)
- Ability to independently identify compliance risks and resolve or escalate as necessary
- Ability to multitask and prioritize
- Based LocallyEducation & Experience
- Bachelor's degree or country equivalent in a relevant scientific discipline
Regulatory Affairs Specialist - Malta - Konnekt
Description
Our client, a global healthcare organization is recruiting for Regulatory Affairs Specialists to join their team. Reporting to the Regulatory Affairs Manager, your duties would include;