26 days old

Director/Senior Director, Medical Device

Lachman Consultants
Remote Work Remotely
  • Job Type
    Employee
  • Job Status
    Full Time

Leadership Opportunity in Medical Device Compliance

No relocation required. This is a remote role with 30%-40% travel to clients (pandemic-permitting).

Lachman Consultants is a global leader in providing cost-effective consultation and remediation services to the pharmaceutical, biotechnology, medical device, biologic, diagnostic, and dietary supplement industries. Our compliance practice, composed of our team of expert consultants from the FDA and industry, offers a wide range of mission-critical services to our clients. We design and implement effective and efficient business processes that ensure sustainable compliance through the optimal integration of scientific, technical, and regulatory principles. We help our clients stay current with the ever-changing regulatory and technical environment and ever-evolving industry practices.

This position is primarily focused on providing medical device quality and compliance review and direction for Lachman clients. In addition to serving as a quality and compliance expert for our medical device clients, you will manage client engagements, assign and manage consultants, partner with and educate clients, and ensure the timely completion of high-quality project deliverables. Expertise in identifying gaps in quality, compliance, and regulatory requirements and in developing efficient and compliant remediation strategies and deliverables will be the key focus of your work.

KEY RESPONSIBILITIES:

  • Provide strategic direction and leadership in developing client relationships, leading multiple complex projects through their life cycles and directing project teams of expert consultants.
  • Research, define, and oversee the production of consulting service deliverables for clients.
  • Manage client engagements, including oversight of consulting time to bring projects to completion on time and within budget.
  • Assess client situations and formulate appropriate client strategic and tactical recommendations that reflect leading industry practices.
  • Maintain comprehensive knowledge about the medical device and related industries, including the ability to understand and interpret current/envisioned regulatory and compliance processes and procedures.
  • Participate in recruiting, training, coaching, and development of the consulting team.
  • Perform risk management on client projects, including documentation and reporting in accordance with Lachman Consultants business requirements/standards.
  • Support and contribute to knowledge management and knowledge sharing.
  • Analyze data.
  • Assist in the development of proposals.

Requirements

  • 10 or more years of regulatory compliance experience in the medical device, life sciences, biologic, and related industries.
  • Deep knowledge of FDA/global compliance trends and the application of regulatory compliance principles in medical device and combination products.
  • 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.
  • Ability to identify gaps in quality, compliance, and regulatory requirements, as well as current expectations. Ability to develop efficient and compliant remediation strategies and deliverables.
  • Practical knowledge of manufacturing and testing methods/strategies.
  • Proven ability to lead complex projects, provide thought leadership, and lead teams to successful outcomes for clients.
  • BS in life sciences or engineering; MS or PhD preferred.
  • Ability to travel nationally and internationally as required (30%-40% annual average).


WE OFFER:

  • An opportunity to join a recognized global leader with a 40-year legacy of providing expert compliance, regulatory affairs, and technical services to clients around the world in a key leadership role.
  • You will join a highly respected team of problem solvers who enjoy a stellar reputation with the FDA and other regulatory bodies. We engage over 20 former FDA investigators and managers, along with other regulatory experts to support our project work.
  • As part of the management team, you will play a critical collaborative role with the executive management team while providing thought leadership and strategic direction to our clients.
  • You will enjoy an industry-leading compensation package, which includes a competitive base salary; annual bonus opportunities; a well-established ESOP plan; two retirement plans: 401(k) and profit sharing; a generous PTO/holiday plan; and a full suite of medical, dental, vision, and life insurance benefits, among others.
  • We provide strong corporate team support for consultants, including in-house travel assistance, technical writing, report preparation/writing, and financial/legal/administrative expertise.

Categories

Posted: 2021-02-03 Expires: 2021-03-05

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Director/Senior Director, Medical Device

Lachman Consultants
Remote

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