Group 10

Zwiers- PLG Group of Companies is hiring a Medical Devices Team Lead to join its MD Teams. The latter will be responsible for the day-to-day operational management and delivery of assigned project portfolio objectives, as agreed with the Senior Manager.

The MD TL will be a  MD Expert; accountable for the regulatory strategy and the execution of it for the relevant customer projects/activities

Responsibilities / Tasks

  • Leads the overall strategy & execution of the assigned project/activities
  • Defines regulatory strategy (RSP, roadmaps, advice) for customers
  • Leads communication with customer about project related and non-project related matters
  • Performs MDR Gap analysis & Due Diligences for customer’s projects
  • Writes and updates Technical Documentation (all parts, including BER & CER) for global applications (e.g. EU, UK, US)
  • Interacts with Notified Bodies and authorities
  • Implements and maintains QMS (e.g. ISO 13485, ISO 9001)

Supervisory Responsibility

  • Functions independently & with a team
  • Leads/Chairs project team
  • Mentoring and training on MD activities of related staff
  • Team Management

Direct reports

  • Project team members

Reports to

  • Director of RA&O

Requirements
Education

  • PhD or MSc in Life Sciences, Medical Biology, Chemistry, Pharmacy

Role Experience

  • Experience as described in Core Function/Tasks/Responsibilities of at least 7 years with an emphasis on Regulatory Affairs & Development
  • Experience in working with different disciplines, experts, Notified Bodies and health authorities (FDA)
  • Preferably experience in other non-EU countries
  • In-depth knowledge and understanding of the MDR & ISO standards

Professional Requirements

  • Excellent communication and presentation skills in English (both written and spoken) – Dutch is a plus
  • Excellent technical writing and editing skills (English)
  • Interpersonal and influencing skills
  • Analytical and problem-solving skills
  • Demonstrated decision-making, strategic thinking skills and leadership responsibilities
  • Good project management and multi-tasking skills
  • Flexible and diplomatic attitude and the ability to manage expectations
  • Ability to deliver under pressure with limited resources
  • Strong computer skills (e.g., MS Office)

Special Requirement

  • Residing in Netherlands
  • Can reside in the EU/UK

Medical Devices Team Lead 287

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