Medical Devices Team Lead

ProductLife Group

Netherlands

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).