Medical Regulatory Affairs

• Title: Regulatory Expert - Medical Devices
• Location: St. Louis, MO 63103
• Duration: 2 year contract w/ temp to perm potential
• Shift: 1st Shift 8am-5pm (Mon- Fri)
• Hybrid: 2-3 days on-site
• Pay rate: $33/hr on W2 without benefits
• Client: Biotechnology

Note-

• IVD products
• Need to understand - IVD regulations/products, medical device regulation for US and Europe
• Quality systems experience - ISO 1345

Duties and 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

Job Type: Contract

Pay: $33.50 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Education:

• Bachelor's (Preferred)

Experience:

• IVD Products: 2 years (Required)
• Regulatory Expert: 2 years (Required)
• Medical Devices: 1 year (Preferred)

Work Location: In person

Salary : $33 - $34