Contribute to ensuring our products meet global regulatory requirements
Work with cross-functional teams to manage product registrations
Maintain compliance documentation
Support regulatory submissions across international markets
Compile technical documentation
Review regulatory requirements
Support product lifecycle management from initial registration through post-market activities
Collect and manage data about chemicals and the CLP classification
Collaborate with business development and procurement teams
Align compliance considerations with strategic goals for portfolio expansion
Collaborate with Commercial teams, Customer Service, Suppliers, Quality Assurance, and regulatory authorities

Bachelor's Degree required, no prior experience required
Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
Additional qualifications in Quality Management or Regulatory Affairs advantageous
Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
Experience with regulatory submissions and documentation management
Strong technical writing and documentation skills
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Excellent organizational abilities and attention to detail
Strong analytical and problem-solving capabilities
Effective verbal and written communication skills in English
Ability to work both independently and collaboratively in a matrix environment
Experience with regulatory databases and submission systems preferred
Knowledge of GMP, ISO 13485, and quality management systems
Ability to manage multiple projects and meet deadlines
Customer-focused mindset with strong interpersonal skills
Demonstrates company values of Integrity, Intensity, Innovation, and Involvement.

Regulatory Affairs Specialist

Key skills