Senior Medical Device Quality & Compliance Expert

Lachman Consultant Services, Inc; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading consultancy in medical device compliance is seeking Medical Device Quality and Compliance Experts to ensure regulatory adherence and efficient remediation strategies. Candidates must have a B.S. in life sciences or engineering and at least 10 years of industry experience to successfully navigate FDA and global regulations. Strong problem-solving and communication skills are essential. Join us in delivering high-quality medical products.

Qualifications

• Minimum of 10 years’ experience in quality and compliance within medical devices.
• Strong background in regulatory compliance with FDA and EU regulations.
• Ability to analyze complex data and identify quality signals.

Responsibilities

• Ensure compliance with FDA and global regulatory requirements.
• Develop and evaluate validation packages.
• Communicate with regulatory bodies effectively.

Skills

Regulatory compliance principles

Medical device design

Quality system regulations

Software as a Medical Device (SaMD)

Molding technology

Excellent communication skills

Problem-solving skills

Education

B.S. life sciences or engineering

Job description

A leading consultancy in medical device compliance is seeking Medical Device Quality and Compliance Experts to ensure regulatory adherence and efficient remediation strategies. Candidates must have a B.S. in life sciences or engineering and at least 10 years of industry experience to successfully navigate FDA and global regulations. Strong problem-solving and communication skills are essential. Join us in delivering high-quality medical products.