Director of Quality Assurance and Regulatory Affairs

Salary: £230000 to £999999
Contact name: Selina Maini

Contact email:
Job ref: 574
Published: about 2 months ago
The company

Medella Life is working with a market leading medical device company who are specialise in redefining respiratory care. They are in the process of expanding their leadership team in the US and are seeking a Director Quality and Regulatory Affairs to join them!   

The role

The Director of Quality Assurance and Regulatory Affairs is a highly motivated, technically competent team builder who can establish and execute a strategic vision, multi-task in a fast-paced work environment, and deliver tangible results for the company’s facility for Class II and I products. The Director will lead and manage the Quality and Regulatory functions to ensure operational compliance with government regulations (US, EU and other applicable country specific regulations) and applicable standards. The Director of Quality & Regulatory Affairs leads the company’s efforts to ensure that our products are in compliance with the company’s quality requirements, in addition to complying with customer and regulatory requirements for quality, safety, and reliability. The position reports to the VP, Quality & Regulatory Affairs.     

  • Member of company’s leadership staff, providing representation for all Quality & Regulatory Affairs functions and personnel.
  • Establish policy and provide oversight for staffing, training, and supervision of Quality & Regulatory team members. Assist direct reports in the recruitment and training of personnel.
  • Partners with senior management, R&D, Manufacturing, and Operations management teams to establish strategic plans, identify responsibilities, and organize schedules for the transfer and ongoing management of product to manufacturing. Monitor Company performance against the established plan.
  • Responsible for the development, implementation, and strict adherence to a quality program in support of FDA cGMP’s and ISO 13485. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the development and production of all products. The Director of Quality & Regulatory has the ultimate authority and decision over the shipment of any product or products and accepts the responsibility for products in compliance with all regulatory and company standards.
  • Reviews and resolves quality control problems/concerns with the suppliers, vendors, customers, quality control personnel, and any personnel related to production.  Coordinates and assists with vendor inspections/audits.
  • Provide direction to the team responsible for quality engineering activities in process and test method validation, process improvements, non-conformance investigation and product disposition, corrective action, complaint management and reporting, and risk management.
  • Report to Executive Management on the status, suitability, and effectiveness of the QMS including quality policies and objectives through the Management Review Process
  • Schedules and performs quality audits and reports findings to the senior leadership and other division leaders; develops corrective action plans and ensures timely resolution of findings. Leads all external compliance audits and regulatory inspections.
  • Prepares reports and other documentation required by regulatory agencies and to support the quality function. Leads and supports 510k and International regulatory submissions.
  • Maintain current knowledge of FDA, ISO, IEC and industry requirements.
  • Supervises, trains, and assists all quality team personnel. Directs quality-related activities in conjunction with Manufacturing, Engineering, Supply Chain, Customer Service, and any other department/function that affects the quality of the organization’s goods or services.
  • Required: Bachelor's degree in Engineering, Quality Assurance, Life Sciences or Business Administration/Management
  • Preference: Master's degree in Engineering, Life Sciences or Business Administration (MBA)
  • 10+ years of experience in Quality Assurance/Quality Management in a manufacturing, preferably medical device, aerospace, or highly regulated industry including FDA, CFR and ISO compliance.
  • Ability to demonstrate strong foundation in process improvement fundamentals.
  • Must have proven ability to lead a diverse team of technicians, specialists, and engineers.
  • The ideal candidate is certified in one or more quality-related disciplines (e.g., CQA, CMQ/OE, PMP)
  • Excellent communication skills and the ability to work well with people at all levels are essential.
  • Must be able to demonstrate strong organizational and managerial skills.
  • Strong computer/technical aptitude.

  • If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything