Employee in Quality Management and/or Regulatory Affairs (m/f/d) at Brainlab Inc

Salzburg, Salzburg, Austria -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Affairs, ISO 13485, EU MDR, Clinical Evaluations, Post-Market Surveillance, Risk Management, CAPA, Audits, Documentation, Team-Oriented, Communication, Medical Devices, International Regulations, Problem Solving, Adaptability

Industry

Medical Equipment Manufacturing

Description

Company Description medPhoton is one of the most innovative companies in Salzburg. Our medical imaging solutions and products stand for the highest quality and are available at medical facilities worldwide. We develop cutting edge medical devices and corresponding software, on our Salzburg premises. Job Description As a professional QM/RA associate, you will be responsible for the following tasks: Support and collaborate across all areas of Quality Management (QM). Ongoing control, improvement, and optimization of quality management processes and standards. Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions. Ensure the implementation and monitoring of regulatory requirements for medical devices. Assist with international product certifications and approvals. Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally). Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards. Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness. Support internal and external audits as well as supplier audits. Assist R&D with documentation and support the development process. Qualifications Experience or training in Quality Management, preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards. Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage. Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines is highly desirable. Knowledge of international regulations and certifications for medical devices is a plus. Fluent in German and English (written and spoken). Flexible, team-oriented, and eager to work in an international environment. We also encourage recent graduates or career changers who are eager to learn and develop in the field of Quality Management and Regulatory Affairs. Additional Information WHAT WE OFFER YOU! A motivating work atmosphere in a young, dynamic team An exciting and varied scope of assignments customized for your skills and interests (e.g. backend services, medical format networking, databases, robotic kinematics, image processing, geometry / visualization, UI/UX...) The opportunity to grow with us, be directly involved and participate in our company’s success A secure, permanent full-time contract Generous social benefits within our culturally diverse enterprise – consisting of 19 nations! Freshly-cooked meals and healthy snacks provided daily Good public transport connections and parking facilities (for both, four and two wheels) available As a family-friendly company, we are happy to support you in your daily obligations (childcare, etc.) by means of flexible working hours. As a family-friendly company, we are happy to support you in your daily obligations (childcare, personal education etc.) by offering flexible working hours. We are also happy to welcome people returning to work and career starters! Ready to apply? We look forward to receiving your online application including your first available start date.

Responsibilities

The role involves supporting and collaborating across all areas of Quality Management and ensuring the implementation of regulatory requirements for medical devices. Additionally, the associate will assist in creating and reviewing deviation reports, risk management plans, and participate in post-market surveillance activities.