Regulatory Affairs Lead, Medical Devices – 12-Month Contract

iMPact Business Group; Cary (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

iMPact Business Group is seeking a Regulatory Affairs Specialist for a 12-month contract in Cary, Illinois. This role involves developing regulatory strategies and ensuring compliance throughout the product lifecycle in the medical device industry.

The ideal candidate will have a BS in Engineering or Science, with a minimum of 6 years of regulatory experience, particularly with US 510(k) submissions. Excellent communication and analytical skills are essential for success.

Qualifications

• Minimum 6 years of experience in regulatory affairs within the medical device industry.
• Extensive knowledge of US and international regulations, especially US 510(k) submissions and EU MDR Class IIa device requirements.
• Strong understanding of compliance, post-market surveillance, and distribution requirements.

Responsibilities

• Assess regulatory intelligence to develop local and global strategies.
• Assist in developing regulatory strategies based on regulations.
• Evaluate proposed products for regulatory classification.
• Provide regulatory information for product development and planning.
• Prepare and submit electronic and paper regulatory submissions.

Skills

Regulatory pathways

Risk-benefit analysis

Compliance

Post-market surveillance

Education

BS in Engineering, Science, or a related field

MS in Regulatory Science or equivalent preferred

Job description

iMPact Business Group is seeking a Regulatory Affairs Specialist for a 12-month contract in Cary, Illinois. This role involves developing regulatory strategies and ensuring compliance throughout the product lifecycle in the medical device industry.

The ideal candidate will have a BS in Engineering or Science, with a minimum of 6 years of regulatory experience, particularly with US 510(k) submissions. Excellent communication and analytical skills are essential for success.