Join our team at a leading Medical Device/Pharma Manufacturing Company in St. Louis, MO! We are seeking a hardworking and motivatedRegulatory Affairs Expert. Don’t wait—apply today!
What's in it for you?

• Role: Regulatory Affairs Expert
• St. Louis MO (Hybrid)
• 2 year contract w/ temp to perm potential.
• Pay Range: $30/hr - $33/hr.
• Full time

Job Description:
We are seeking a highly skilled and motivated Regulatory Affairs Expert to join our team in the medical devices sector. With minimal supervision, you will manage assigned regulatory tasks related to health authority notifications, submissions, and registrations for renewals, new products, and product changes. Your role will ensure continual compliance with all applicable regulations and align site regulatory strategy with our corporate goals and objectives.
Key Responsibilities:

• Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals.
• Maintain a library/database of technical documentation.
• Monitor the status of standards and regulations, conducting reviews and analyses as requested.
• Assist and advise in activities related to regulatory registrations, listings, and compliance, particularly focusing on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
• Ensure compliance with FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other international medical device regulations.
• Review and update documentation requirements, disseminating relevant information throughout the site.
• Manage regulatory reviews for CAPA investigations, adverse events, validations, and general projects.
• Support preparation for and participate in audits by regulatory bodies.
• Analyze new registration requirements to determine business impact and document as necessary.
• Respond to internal and external customer regulatory requests and inquiries.
• Support recall or notification actions and carry out regulatory vigilance reporting as required.
• Act as a liaison between the site and internal/external in-country representatives.
• Maintain records of registration activities and license changes utilizing Good Documentation Practices.

Who You Are:
Minimum Qualifications:

• Bachelor's or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science disciplines.
• 2 years of professional experience in Regulatory Affairs (IVD).

Preferred Qualifications:

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

Why should you choose Experis?

• Medical, Dental, Vision, 401k
• Weekly pay with direct deposit
• Consultant Care support
• Free Training to upgrade your skills.
• Dedicated Career Partner to help you achieve your career goals.

Are you Interested?
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