Benefits:

401(k)

401(k) matching

Bonus based on performance

Competitive salary

Paid time off

Profit sharing

Title: Compliance Engineer Lead - Medical Devices & Combination Products

Company Overview:

Our Client stands at the intersection of innovation and regulation in the medical device and life sciences industries. As a beacon of expertise, They guide clients through the complex landscape of regulatory compliance and quality management. Their mission is to accelerate the delivery of groundbreaking healthcare solutions, ensuring they meet rigorous standards for safety and efficacy. Join us in our commitment to shaping the future of healthcare, where every project advances technology, enhances patient care, and contributes to the global well-being.

Our Client is located in the heart of the North Carolina Triangle, an area geographically framed by Raleigh, Durham, and Chapel Hill North Carolina. This rich community includes North Carolina State University, Duke University, the University of North Carolina – Chapel Hill and many other higher education institutions of high repute. It is, in the opinion of many, an Atlantic Coast Conference heaven and also boasts a professional hockey team, the Hurricanes. U.S. News & World Report's Best Places to Live rankings put the Triangle as the number 2 place to live in the country in 2021 and the number 3 place to live in 2023.

Job Description: As a Compliance Engineer Lead, you will play a pivotal role in supporting our Regulatory and Quality initiatives, mentoring a team of engineers, and taking charge of client relationships for select projects. Your responsibilities will include conducting QA gap assessments, customizing client QMS, leading audit activities, and applying design control principles to ensure compliance and enhance client processes.

Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related field.

• 4-6 years of industry experience in medical device or combination device sectors.

• Proven track record in submitting and defending FDA and CE mark submissions.

• Deep knowledge in developing and implementing Quality Management Systems.

Desired Skills:

• Consultancy experience or strong consultative skills.

• Understanding of Software Development Lifecycle and Design.

Benefits and Compensation:

• Competitive salary based on experience.

• Comprehensive benefits package including health, dental, and vision.

• Opportunities for professional development and growth.

Keywords: Medical Device, Quality Assurance, Regulatory Affairs, Compliance Engineer, Quality Management Systems, FDA, CE Mark, Audit, Consultancy.

Diversity Statement:

MethodSense is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.