The Regulatory Specialist supports the Laboratory Plastics Essentials business by ensuring product safety and regulatory compliance across global manufacturing sites
Job Summary
The Regulatory Specialist supports the Laboratory Plastics Essentials business by ensuring product safety and regulatory compliance across global manufacturing sites.
Key responsibilities include updating CE technical files, reviewing non-conformance reports, and acting as a subject matter expert on new product introductions.
The role requires collaborating with global teams to manage environmental compliance information and support internal and external audits.
Matching Summary
The Regulatory Specialist supports the Laboratory Plastics Essentials business by ensuring product safety and regulatory compliance across global manufacturing 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 or engineering field
TrackWise quality management system usage
Nice-to-have
Technical writing experience for reports
Notified Body audit participation skills
REACH/SVHC and California Prop 65 knowledge
Innovative problem-solving ability
Strong critical thinking and decision-making
Key Requirements
Minimum BA/BS degree in biology, chemistry, material science, or polymer science
At least 2 years of experience in pharmaceutical or medical device industry
Strong working knowledge of US and EU Medical Device regulations