QM Associate - Regulatory Affairs

Stellenbeschreibung:

Job Description

You are interested in Regulatory Affairs or in the development of medical devices? As QM Associate in our Regulatory Affairs team you will interact with Brainlab departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Brainlab products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.

Review Technical documentation before CE marking a new/changed medical device
Evaluate and follow up design changes during the development and implementation
Discuss regulatory topics with R&D colleagues and other departments
Support global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries
Support regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities
Monitor & investigate regulatory requirements in pre-defined countries
Participate in regulatory audits and follow up improvement opportunities
Review marketing material
Support the release of third party devices
Train Brainlab employees in regulatory requirements

Qualifications

Degree in engineering or life sciences preferred, but other degrees may be considered
Professional experience in regulatory affairs or regulatory compliance in the medical device field is an advantage. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
Excellent English written and verbal communication skills
Ability to communicate with all stakeholders
Persuasive power