Employee in Quality Management andor Regulatory Affairs (mfd)

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 companys 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.

Remote Work :

No

Employment Type :

Full-time

Key Skills
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Department / Functional Area: Quality Management
Experience: years
Vacancy: 1