Regulatory Expert - Medical Devices

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Merck Group seeks a Regulatory Expert for Medical Devices to join the South Ewing facility in St. Louis, MO, full-time onsite. You will autonomously compile and maintain technical files and regulatory documentation to ensure timely registrations and renewals, oversee surveillance activities, and support regulatory reviews for CAPA investigations, adverse events, validations, audits, and labeling. Ensure compliance with IVDR 2017/746 and global regulations including FDA 21 CFR 820 and ISO 13485:2016, and serve as the primary regulatory contact for internal and external stakeholders. Requirements: bachelor’s degree and 2+ years in pharma; IVDR and ISO 13485 experience preferred. This role does not offer sponsorship; US work eligibility is required. Pay: $75,200 to $112,800 plus benefits. Apply with a tailored resume highlighting regulatory submissions, audits, labeling, and cross-functional collaboration, and your readiness to work onsite.

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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 any discipline.
• 2+ years of experience in the Pharmaceutical industry.

Preferred Qualifications:

• 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.

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