Talentify
Remote Sr. Regulatory Affairs Specialist
This job is now closed
Job Description
- Req#: JP-003972887
employer is seeking a candidate to join our Regulatory Affairs department within the Toxicology unit. As part of our team, you will have the opportunity to contribute to the development of innovative in vitro diagnostic products and ensure compliance with regulatory requirements. Join employer and make a difference in the lives of patients worldwide.
Responsibilities:
- Obtain relevant product data and information
- Understand source information
- Convert relevant product data and information into clear, complete, and accurate documentation that meets submission requirements
- Review scientific literature for applicability in product technical file documentation
- Provide critical analysis of conclusions drawn from clinical evidence to meet regulatory requirements
Skills:
- Regulatory Affairs
- IVD and IVDR knowledge
- Technical Files
- Technical Writing
- Medical Writing
Requirements:
- Bachelor’s degree in a scientific field
- 3-5 years of experience in medical device regulatory affairs
- Experience writing IVDR technical file documents
- Strong organizational skills for cross-functional product submission preparation
Additional Information:
employer is an equal opportunity employer. Diversity and inclusion are integral to our culture, and we strive to create an inclusive environment for all employees. We offer growth opportunities and a culture of care, engagement, and recognition. Join employer and be part of a company that connects passion with purpose.
About employer:
employer connects passion with purpose by providing specialized engineering and science expertise to help companies advance their initiatives. With a network of experts and clients worldwide, employer serves many Fortune 500 companies. As part of Allegis Group, the global leader in talent solutions, employer is committed to delivering exceptional services and driving innovation.About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.