Vacancy Description
About the Role
We are seeking an experienced Senior Regulatory Affairs Specialist to join a SME Medical Device company. This is a key role responsible for ensuring our medical devices meet global regulatory requirements and maintain compliance across all markets.You'll play a pivotal role in supporting product registrations, maintaining technical documentation, and working closely with cross-functional teams to ensure regulatory excellence throughout the product lifecycle.
What You'll Be Doing
As a Senior Regulatory Affairs Specialist, you will:
Regulatory Submissions & Compliance
Prepare and submit regulatory documentation and product registration dossiers
Maintain regulatory approvals, licences, and certificates across the portfolio
Coordinate renewals to ensure continuous market access
Technical Documentation & Clinical Evaluation
Develop and maintain Technical Documentation in line with EU MDR (2017/745) and ISO 13485
We are seeking an experienced Senior Regulatory Affairs Specialist to join a SME Medical Device company. This is a key role responsible for ensuring our medical devices meet global regulatory requirements and maintain compliance across all markets.You'll play a pivotal role in supporting product registrations, maintaining technical documentation, and working closely with cross-functional teams to ensure regulatory excellence throughout the product lifecycle.
What You'll Be Doing
As a Senior Regulatory Affairs Specialist, you will:
Regulatory Submissions & Compliance
Prepare and submit regulatory documentation and product registration dossiers
Maintain regulatory approvals, licences, and certificates across the portfolio
Coordinate renewals to ensure continuous market access
Technical Documentation & Clinical Evaluation
Develop and maintain Technical Documentation in line with EU MDR (2017/745) and ISO 13485
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