Regulatory Affairs Specialist - Medical Devices

Regulatory Affairs Specialist - Medical Devices- 6 months contract

Global Medical Devices company is looking for Regulatory Affairs Specialist to support Life cycle management activities for sterilization site change from external to internal manufacturing
OVERALL RESPONSIBILITIES
Support the internal Regulatory Affairs group in creation and maintenance of technical documentation
supporting compliance to according to European Council Directive 92/42/EEC/Regulation 2017/745, as applicable,
Ensuring that the company's products comply with the regulations set up by government
agencies
Assisting with reviewing of product and process documentation for assigned projects to ensure
compliance with change control requirements to aid in determining if regulatory submissions are
required
Creation, review and maintenance of regulatory related technical documentation
Capturing and verification of regulatory product characteristics to support logistic and supply
chain efforts on a global scale
Working with cross-functional teams to obtain relevant information and subsequent review of
submission content as needed; assist in review of international product technical documents,
marketing and labeling materials
Supporting team's daily operations of regulatory processes to ensure compliance with routine
regulatory reporting obligations
Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals

EXPERIENCE REQUIREMENTS:

Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience)

experience in European Medical device industry especially with regulatory, quality or engineering
Strong knowledge of ISO 13485 and ISO 9001, QSR - Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, MEDDEV guidance documents applicable to Medical Devices products and processes
knowledge of FDA requirements registration requirements in further global markets would be an asset

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.