Regulatory Expert – Medical Devices
Location: St. Louis, Missouri, USA
Job Type: Full-Time
Company: MilliporeSigma
Job ID: 293130
Position Overview
MilliporeSigma is seeking a Regulatory Expert – Medical Devices to support global regulatory compliance, technical documentation, and product registrations. This role is responsible for compiling, maintaining, and updating regulatory files to ensure timely submissions, renewals, and adherence to international medical device regulations. The position is based at the South Ewing facility in St. Louis.
Note: This role does not include sponsorship. Applicants must be legally authorized to work in the United States.
Key Responsibilities
Prepare, update, and maintain technical files and regulatory documentation for global medical device registrations and renewals.
Conduct regulatory surveillance activities and support compliance initiatives for assigned medical devices.
Ensure compliance with global regulatory frameworks including:
EU IVDR (2017/746)
FDA 21 CFR 820
CMDR SOR 98-292
ISO 13485:2016
Manage regulatory review for CAPA investigations, adverse events, validations, and other regulatory-critical processes.
Participate in regulatory authority and customer audits, ensuring readiness and documentation accuracy.
Review labeling materials including labels, inserts, IFUs, and promotional content, ensuring full regulatory compliance.
Provide regulatory guidance and assessments for new product development projects.
Serve as the primary regulatory contact for internal departments and address regulatory queries from both internal and external stakeholders.
Required Qualifications & Experience
Minimum Qualifications:
Bachelor’s degree in Regulatory Science, Biology, Immunology, Pharmacology, or a related scientific or medical discipline, and at least 1 year of regulatory experience with medical devices.
OR
Master’s degree in Regulatory Science, and at least 1 year of experience implementing:
EU IVDR (2017/746)
US 21 CFR 820
ISO 13485:2016
Preferred Qualifications:
3+ years of experience implementing IVDR, FDA 21 CFR 820, and ISO 13485:2016.
Strong understanding of global medical device regulatory frameworks.
Excellent documentation, communication, and cross-functional collaboration skills.
Ability to interpret regulations, assess compliance risks, and support technical and quality initiatives.
Compensation & Benefits
Pay Range: USD $75,200 – $112,800 per year
(Final compensation depends on experience, education, skills, and location.)
Eligible for performance-based bonuses
Comprehensive employee benefits including:
Health insurance
Paid time off (PTO)
Retirement plan contributions
Additional company-provided benefits and perks
Why Join MilliporeSigma?
MilliporeSigma offers a collaborative and inclusive environment that values diversity, innovation, and continuous learning. As part of a global science-driven organization, you will contribute to advancing healthcare, life science, and technology solutions that impact millions worldwide. The company supports professional growth, personal development, and an empowering workplace culture.
Apply Now
If you are a regulatory professional with medical device experience and a strong understanding of global compliance standards, we invite you to apply and join a team committed to driving scientific excellence and regulatory integrity.
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