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