Regulatory Expert - Medical Devices

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

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. 

Your Role:

In this role you will autonomously compile and maintain technical files and other relevant regulatory documentation to guarantee timely registrations and renewals. This position is located at our South Ewing facility. 

Responsibilities include but are not limited to:

• Perform surveillance and advocacy activities for medical devices as assigned.
• Provide support and counsel on regulatory registrations, listings, and compliance.
• Ensure adherence to the IVDR (EU) 2017/746 and other global regulations (e.g., FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016).
• Manage regulatory review for CAPA investigations, adverse events, validations, and general projects.
• Support preparation for and participates in audits by regulatory authorities and customers.
• Conduct regulatory review of labeling materials (labels, IFU, inserts, promotional) and provides compliance consultancy.
• Support new product development projects through timely regulatory assessments.
• Act as the primary regulatory contact for internal departments and addresses regulatory queries from both internal and external stakeholders.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Regulatory Science, Biology, Immunology, Pharmacology, or other Science or Medical discipline and 1+ years of experience in Regulatory Affairs with medical devices.

OR

• Masters Degree in Regulatory Science.
• 1+ years of experience implementing In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), US 21 CFR 820, ISO 13485:2016.

Preferred Qualifications:

• 3+ years of experience implementing In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), US 21 CFR 820, ISO 13485:2016.

Pay Range for this position: $75,200 - $112,800 / year​

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!