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 a Director of Medical Devices for its Compliance practice.
Qualifications / Responsibilities include:
• Current understanding of FDA and rest of world compliance trends in medical devices and combination products
• Experience developing communications to regulatory bodies, providing written responses and updates, attending agency meetings
• Working knowledge of FDA quality system regulations
• Working knowledge of EU medical device regulations
• Working knowledge of 21 CFR Part 211
• Clear understanding of combination product compliance with US and EU regulations and guidance
• Ability to directly apply skill sets in design controls and process validation
• Ability to identify appropriate standards and apply knowledge to development of design history files
• Ability to evaluate validation packages for compliance to applicable regulations and standards
• Diverse background in materials
• Diverse background in dosage forms
• 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
• Excellent written and oral communication skills
• Excellent interpersonal and soft skills
• Ability to lead and negotiate
• Ability to solve problems using innovative techniques
• Willingness to work nights and weekends as required
• Willingness to travel globally, sometimes on short notice
Educational requirements include:
• B.S. life sciences / engineering (prefer EE/ME degree(s)) & 10 years’ 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.