Regulatory Affairs Associate

Regulatory Affairs Expert-Medical Devices

1 Year (Extendable & potential to convert)

St Louis, MO

Max PR: $25-33/hr

Your Role:

With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.

Responsibilities

Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals

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 for and participate in audits by regulatory bodies

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

Minimum Qualifications:

Bachelor's or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline

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