The Regulatory Affairs Senior Specialist plays a key role in ensuring regulatory, quality, and safety compliance across a diverse regional portfolio
Job Summary
The Regulatory Affairs Senior Specialist plays a key role in ensuring regulatory, quality, and safety compliance across a diverse regional portfolio.
In this senior position, you will act as a trusted subject matter expert, partnering with internal teams and external stakeholders to maintain audit readiness, support market access, and uphold the highest standards of regulatory governance across multiple EMEA countries.
The opportunity to make a meaningful impact on patient safety and product compliance across a broad and varied EMEA portfolio.
Matching Summary
The Regulatory Affairs Senior Specialist plays a key role in ensuring regulatory, quality, and safety compliance across a diverse regional portfolio.
Skills & Requirements
Must-have
regulatory compliance
medical device vigilance
documentation for shipping
product and site compliance
Safety Data Sheets (SDS)
hazard labelling
Nice-to-have
working with regulatory authorities
familiarity with EPR schemes
supporting inspections or audits
additional European language skills
Key Requirements
Proven experience in regulatory affairs
demonstrable exposure to EMEA markets
Strong working knowledge of relevant EMEA and local regulations