Medical Devices Expert/ Team Lead Full-time Job

Zwiers- PLG Group of Companies is hiring a Medical Devices Expert/ 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)

ProductLife Groups mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.
Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.