Medical Device Quality and Compliance Experts

Lachman Consultant Services, Inc; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking Medical Device Quality and Compliance Experts to join its team of professionals. This role involves ensuring adherence to FDA and global compliance trends while developing efficient remediation strategies. Candidates will leverage their expertise in medical device design and regulatory requirements to identify gaps and provide compliant solutions. The ideal candidate will possess a strong background in Software as a Medical Device, molding technology, and quality system regulations. This is a unique opportunity to contribute to the development of high-quality medical products in a dynamic and supportive environment.

Qualifications

• 10 years of experience in medical device quality and compliance.
• Strong understanding of FDA and global compliance trends.
• Ability to analyze complex data to identify quality signals.

Responsibilities

• Identify gaps in quality and develop remediation strategies.
• Support 510(k) applications and evaluate validation packages.
• Communicate with regulatory bodies and attend agency meetings.

Skills

FDA compliance

regulatory compliance

medical device design

process validation

Software as a Medical Device (SaMD)

molding technology

ISO 13485

in vitro diagnostics

quality system regulations

problem-solving

Education

B.S. in life sciences or engineering

Job description

Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic, and dietary supplement industries, is seeking Medical Device Quality and Compliance Experts with specialized skills in combination products; in vitro diagnostics; molding technology and resins; Software as a Medical Device (SaMD); and creation and remediation of medical device and combination product Design History Files / Technical Files to join its cadre of medical device professionals. The ideal candidate can identify gaps in quality, compliance, regulatory requirements, and current expectations, and develop efficient, compliant remediation strategies and deliverables.

Qualifications / Responsibilities include:

• Current understanding of FDA and global compliance trends and application of regulatory compliance principles in medical devices and combination products.
• Ability to directly apply skill sets in medical device design, design controls, and process validation.
• Clear understanding of in vitro diagnostic (IVD), metered dose and dry powder inhalation products, transdermal/transcutaneous patches, nasal spray, PFS, autoinjectors, and ophthalmic device / combination product compliance with US and EU regulations and guidance.
• Ability to identify appropriate standards and apply knowledge to development and remediation of design history files/technical files.
• Highly experienced in Software as a Medical Device (SaMD) and software validation.
• Experience with molding technology, plastics, and resins.
• Working knowledge of FDA quality system regulations.
• Application of US FDA regulations, 21 CFR Parts 4, 11, and 820.
• Working knowledge of 21 CFR Part 211.
• Working knowledge of ISO 13485 and 14971.
• Working knowledge of EU medical device regulations (MDR).
• Working knowledge of in vitro diagnostic regulations (IVDR).
• Ability to support 510(k) and other applications at CDRH/FDA.
• Ability to evaluate validation packages for compliance with applicable regulations and standards.
• Experience developing communications to regulatory bodies, providing written responses and updates, attending agency meetings.
• Diverse background in various classes and families of devices, product codes, as well as materials.
• Ability to analyze complex data across sources to identify quality signals.
• Ability to solve complex problems in quality, including management of non-conformances, deviations, and CAPA.
• Ability to offer detailed, practical, and compliant solutions to identified quality system and regulatory gaps.
• Ability to solve problems using innovative techniques.
• Excellent written and oral communication skills.
• Excellent interpersonal and soft skills.
• Ability to lead and negotiate.
• Willingness to work nights and weekends, as required.
• Willingness to travel globally, as necessary.

Educational requirements include:

• B.S. in life sciences or engineering and 10 years of experience.

For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic, and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective, and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable, and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.