MDR Supplier Lead

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United States
Raynham, Massachusetts
Posting date: 15 Apr 2019

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for an MDR Supplier Lead position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its US-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • Manage the Key Deliverables for External Manufacturing for the MDR program from concept through execution.
  • The Supplier Lead role is to lead External Manufacturing activities for MDR project to ensure that MDR compliance is achieved without any service disruption to customers or significant cost implications to the business.
  • Ensures that the suppliers provide purchased finished goods, direct and indirect materials or services that align with Global Regulations and industry standards.
  • Using a risk-based approach, the SRM handles the MDR Readiness Control Process and leads the Supplier Engagement Workstream for MDR.
  • Manage supplier engagement & communication for applicable supplier scope
  • Conduct MDR supplier risk categorization
  • Use supplier risk categorization to work with Product Execution Leadership Team (PELT) and SELT team to update cadence and ensure work packets initiated early for priority/ high risk codes
  • Where necessary, negotiate an agreement to ensure that MDR compliance is achieved on time through a solution that optimizes service, inventory and cost.
  • Support Supplier Quality for Tech File readiness - including Material and Product Information & Risk Management Activities for all related suppliers
  • Manage suppliers for change control execution for MDR - includes coordinating with SQ, Tech Ops, Labelling, Packaging
  • Manage supplier for supply chain readiness - work with External Operations and Supply Chain Planning to determine and execute supply strategy at code level
  • Provide input to SKU level supply chain readiness execution plan
  • Plan, schedule and track supplier activities and timelines using appropriate tools
  • Schedule & facilitate risk status meetings with the aim to advise Core Team on project status, risk and mitigation
  • Partner with Procurement, Manufacturing and R&D to manage and mitigate supplier risk across the product lifecycle.
  • Ensure you make appropriate resource and budget and allocation decisions. Takes a leadership role in engaging key partners to scope projects, resources, budgets and timelines to ensure execution.
  • Ensures compliance to applicable Global Regulations and standards (e.g QSR, ISO, EN, and Medical Device Regulation (MDR) requirements).

Skills and Requirements:

  • Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
  • Certificates in Program/Project Management will enhance candidacy but are not a requirement.
  • 2 years of experience in teaching, coaching and adult learning.
  • Experience managing business projects and/or supplier relationships
  • Experience managing business projects and/or supplier relationships
  • Experience in leading project teams and implementing complex projects.
  • Experience in Sales & Marketing and Sales Force Effectiveness would be of advantage.
  • Experience teaching agile ways of working.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Maya Smith at + 267-405-6995 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.