Regulatory Expert - Medical Devices

Your Role: 

MilliporeSigma has a current opening for a Regulatory Expert - Medical Devices (Hybrid).  With minimal supervision, you will manage assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products in new territories ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.  

  

This hybrid role will report to our St. Louis facility.  

  

• Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals (removed device master records) 

• Maintain library/database of technical documentation 

• Monitor the status of standards and regulations. Conduct a review and analysis in case if requested. Assist and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations. 

• Review updated documentation requirements and carry out documented review, ensuring any necessary updates are made; disseminate relevant information throughout the site 

• Manage regulatory review for CAPA investigations, adverse events, validations, and general projects (removed printed materials & added adverse events) 

• Support preparation of and participate in all customer audits which require regulatory input 

• Support preparation for and participate in audits by regulatory bodies 

• Manage regulatory review for labeling materials including labels, instructions for use, package inserts, advertising/promotions, and websites 

• Support new product development projects which require regulatory input 

• Analyze new registration requirements to determine impact to the business and/or site and document as necessary 

• Respond to internal and external customer regulatory requests and/or inquiries 

• Support any recall or notification actions and carry out regulatory vigilance reporting as required 

• Act as liaison between site and internal and external in country representatives 

• Maintain records of registration activities and license changes utilizing Good Documentation Practices 

  

Who You Are: 

  

Minimum Qualifications: 

• Master’s Degree in Life Science (Chemistry, Biology, etc.), Engineering (Chemical Engineering, Mechanical Engineering, etc.), or Pharmacy with 1+ years of professional experience in Regulatory Affairs (IVD) 

OR 

• Bachelor’s Degree in Life Science (Chemistry, Biology, etc.), Engineering (Chemical Engineering, Mechanical Engineering, etc.), or Pharmacy with 3+ years of professional experience in Regulatory Affairs (IVD) 

  

Preferred Qualifications: 

• Depth and breadth of expertise combined with in-depth knowledge of market, competitors, and authority landscape 

• Experience with in-vitro diagnostics 

• Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology 

• Excellent organizational, prioritization, and problem-solving skills 

• Excellent project management skills 

• Ability to work independently and effectively manage multiple tasks/projects with varying deadlines and requirements 

• Proficient in MS Office Software (Word, Excel, PowerPoint) 

• Excellent technical and report writing skills 

• Ability to effectively work both in a team situation and individually with minimal supervision 

 

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