Sr. Regulatory Affairs - IVD Subject Matter Expert (Hybrid)

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

**This position may include a relocation assistance.**

Your Role:

MilliporeSigma has a current opening for a Sr. Regulatory Affairs - IVD Subject Matter Expert (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 Spruce/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 Pharmacy, Chemistry, Biology, Engineering, or other Life Science field 
• 1+ years of professional experience in Regulatory Affairs (IVD)

OR

• Bachelors degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science field
• 2+ 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

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html