Regulatory Compliance Engineer EN

About TSC PTM

The Surgical Company International is a global, innovative, successful and fast-growing medical device company (Class I, Is, IIa and IIb) for Patient Temperature Management, among others, both for Forced Air Warming and Blood and Fluid Warming. Our products are used in hospitals in more than 50 countries worldwide. TSC-PTM is part of The Surgical Company Group with 370 employees. TSC has R&D and manufacturing sites in the Netherlands, England and France.

The Global Regulatory Affairs team is looking for a motivated:                                 

Regulatory Compliance Engineer:

(Amersfoort Location)  

Responsible for the daily coordination and execution of the RA processes and activities within TSC-PTM.  This includes: product registrations in various countries, technical documentation, Change Control.

You are point of contact towards the internal departments (R&D, QA, Supply Quality) as well as the external stakeholders (Test houses, Notified Body, Competent Authorities in the various countries) of TSC-PTM.

Responsibilities:

- Independently maintain the Technical File of a PTM product group.

- Assessing R&D proposed changes through regulatory assessment and coordinating follow-up steps.

- Maintain contacts with Competent Authorities and ensure an effective registration process (often via local distributors).

- Participating in improvement projects / teams and (internal) audits.

Competencies and core values:

- University (of applied sciences) education (or equivalent through experience) and at least 2 years of experience in Quality or Regulatory in the Active medical device industry.

- Knowledge of Medical Device Regulations.

- Good command of the English languages in word and writing.

- Flexible, pragmatic, analytical and structured.

- Team player, customer-oriented and motivated.

- Takes responsibility for own work.

What The Surgical Company offers:

- Work with medical devices developed in-house and produced in the Netherlands and France.

- Varied work in an enthusiastic young team in a healthy and rapidly growing company.

- Good working conditions and pension plan.

- Internal and external training