Medical Device Quality and Compliance Experts
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 both 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 rest of world 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 and 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 to 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. life sciences or engineering and 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. Apply tot his job
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