Regulatory Affairs Specialist, Med Devices — Remote Contract

GForce Life Sciences; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading life sciences company is seeking a Regulatory Affairs Specialist for a 12-month contract. The role involves developing regulatory strategies and ensuring compliance with U.S. 510(k) and EU MDR requirements. Candidates should have at least 5 years of experience in the medical device industry and a Bachelor's degree in a relevant discipline. This position offers remote work options during CST hours, with a preference for candidates local to Cary, IL.

Qualifications

• 5+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of U.S. FDA 510(k) and EU MDR requirements for Class IIa devices.
• Proven ability to develop regulatory strategies and manage documentation remediation.

Responsibilities

• Remediate and update regulatory documentation to ensure compliance with U.S. 510(k) and EU MDR requirements.
• Develop and maintain global, regional, and multi-country regulatory strategies aligned with business objectives.
• Review and evaluate preclinical, clinical, and manufacturing changes for regulatory filing needs.
• Collaborate with cross-functional teams and regulatory authorities on complex issues throughout the product lifecycle.

Skills

Regulatory documentation remediation

Regulatory strategy development

Communication skills

Analytical skills

Education

Bachelor's degree in a scientific or engineering discipline

Job description

A leading life sciences company is seeking a Regulatory Affairs Specialist for a 12-month contract. The role involves developing regulatory strategies and ensuring compliance with U.S. 510(k) and EU MDR requirements. Candidates should have at least 5 years of experience in the medical device industry and a Bachelor's degree in a relevant discipline. This position offers remote work options during CST hours, with a preference for candidates local to Cary, IL.