The Regulatory Specialist supports the global mission to make the world healthier by ensuring product safety and regulatory compliance across multiple international sites
Job Summary
The Regulatory Specialist supports the global mission to make the world healthier by ensuring product safety and regulatory compliance across multiple international sites.
Key responsibilities include updating CE technical files, reviewing non-conformance reports, and acting as a subject matter expert for new product introductions and capacity expansion projects.
The role requires close collaboration with global manufacturing teams in Mexico and Germany to manage environmental compliance and support external audits by Notified Bodies.
Matching Summary
The Regulatory Specialist supports the global mission to make the world healthier by ensuring product safety and regulatory compliance across multiple international sites.
Skills & Requirements
Must-have
EU MDR/IVDR Technical Files expertise
US and EU Medical Device requirements knowledge
2 years regulated industry experience
BA/BS degree in scientific field
Technical writing and documentation skills
Nice-to-have
Experience with REACH/SVHC and RoHS compliance
Critical thinking and decision-making abilities
Team-building and collaboration skills
Innovative problem-solving approach
Flexibility to handle shifting priorities
Key Requirements
Minimum BA/BS in biology, chemistry, or engineering
At least 2 years in pharmaceutical or medical device industry