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.
location: Saint Louis, Missouri
job type: Contract
salary: $28 - 33 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
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
qualifications:
Required:
- Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline
- 2+ years of professional experience in Regulatory Affairs
- Knowledge of in-vitro diagnostics (IVD)
- Proficient in MS Office Software (Word, Excel, PowerPoint)
- Master's degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline
- Experience with in-vitro diagnostics (IVD)
- Depth and breadth of expertise combined with in-depth knowledge of market, competitors, and authority landscape
- 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
- Excellent technical and report writing skills
- Ability to effectively work both in a team situation and individually with minimal supervision
skills: MS-WORD, MS-EXCEL, Biology, Chemistry, In Vitro
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
