Coloplast AS is seeking a Regulatory Affairs Specialist to ensure compliance with medical device regulations throughout the product lifecycle. The ideal candidate should have at least three years of experience in regulatory affairs or quality assurance in the medical device industry, along with strong communication skills in both English and French
Job Summary
Ensure regulatory compliance of medical devices throughout their lifecycle for countries including US, Canada, Japan, Australia, and emerging markets.
Support product development and modification activities, including validation of packaging, promotional materials, and Design History Files (DHF).
Manage and coordinate the STEP regulatory database, including MDM and EU declarations of conformity, contributing to regulatory knowledge and best practices.
Matching Summary
Match Score: 85
Coloplast AS is seeking a Regulatory Affairs Specialist to ensure compliance with medical device regulations throughout the product lifecycle. The ideal candidate should have at least three years of experience in regulatory affairs or quality assurance in the medical device industry, along with strong communication skills in both English and French.
Skills & Requirements
Must-have
Regulatory compliance for medical devices
Lifecycle management of product registrations
Regulatory strategy development
Technical documentation review
Regulatory intelligence and impact analysis
STEP database management
Nice-to-have
Experience in project management
Commitment to inclusive organization
Key Requirements
Minimum 3 years of experience in Regulatory Affairs or Quality Assurance
Experience with Class I, II, and III medical devices
ISO and FDA certified company experience
Excellent written and oral communication skills in English and French