Quality and Regulatory Specialist

Adaptive Business Group; Stuttgart; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Join a pioneering team as a Quality and Regulatory Specialist at a leading medical technology firm. You'll ensure compliance with ISO standards and regulatory requirements while driving quality initiatives. This role offers a collaborative environment to shape cutting-edge surgical solutions.

Leistungen

Flexible hours

Bike leasing

Balanced male/female ratio

Active growth in R&D

Qualifikationen

• 3 years of professional experience in a regulatory environment.
• Knowledge of ISO 13485.
• Must have presentation and moderation skills.

Aufgaben

• Maintaining the quality management system according to ISO 13485.
• Preparation and implementation of internal audits.
• Documentation and evaluation of quality indicators.

Kenntnisse

Analytical thinking

Structured working

Communication skills

Ausbildung

Degree in engineering, medical technology, or quality management

Jobbeschreibung

Join a dynamic team where innovation and excellence in the medical technology field come to life!

As a Quality and Regulatory Specialist, you will be crucial in maintaining our high standards and ensuring compliance with industry regulations. Become part of a team that thrives on innovation and is dedicated to delivering the highest quality solutions for surgical applications.

In this exciting position, you will engage in a variety of responsibilities, from overseeing internal and external audits to processing complaints and collaborating on regulatory projects. Your contributions will help shape the future of the client's product portfolio, ensuring that it continues to lead the market with excellence.

Key Responsibilities

• Maintaining and continuously developing the quality management system in accordance with ISO 13485 and MDSAP
• Preparation and implementation of internal and external audits and monitoring of certification processes
• Planning, implementation, and monitoring of validation and verification activities
• Creation and maintenance of technical documentation in accordance with MDR
• Internal and external contact for regulatory issues and projects
• Documentation and evaluation of quality indicators for the continuous improvement of our products and processes
• Compilation of registration documents for international registrations
• Contact person for regulatory authorities

Required Qualifications and Skills

• Degree in engineering, medical technology, quality management, or a comparable qualification
• 3 years of professional experience in a regulatory environment and experience in quality management, ideally in medical technology
• Knowledge of ISO 13485
• Analytical thinking as well as a structured and independent way of working
• High level of reliability and initiative
• Good presentation, moderation, and communication skills
• Independent and at the same time team-oriented way of working

Benefits and Perks

• Flexible hours
• Bike leasing
• Balanced male / female ratio (2 : 2)
• Actively growing R&D function and product portfolio

Who Are Adaptive Life Science?

Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.

We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.

Why Apply With Us?

Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including :

• Expert advice on your CV and cover letter
• Guidance on salary expectations
• Personalized interview preparation
• Connections to exclusive job opportunities
• Assistance in negotiating the best possible offers
• 50% of the CVs we send to clients are accepted
• Accepted or declined, either way we will provide you with feedback

We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.

Who Do Adaptive Work With?

We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.

If you are interested in this role, please apply with your CV or contact Alisa Liddell for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.