Quality Assurance Manager

vor 2 Wochen

Rohrdorf, Deutschland Medi-Globe Group Vollzeit

**About Us**

The Medi-Globe Group is a dynamic and innovative company in the medical technology industry, specializing in urology and gastroenterology.

We have a strong presence in the market with our four brands: Urotech GmbH, Urovision GmbH, Medi-Globe GmbH, and Endo-Flex GmbH. Our team of experts has been developing, producing, and marketing innovative medical instruments for over 35 years, with a focus on precision and excellence.

We are a company that values innovation, teamwork, and customer satisfaction. Our team of over 670 employees is dedicated to creating solutions that meet the needs of our customers and the medical community.

**Job Summary**

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our medical devices in the EU and globally.

**Key Responsibilities**

• Conducting regulatory activities for our medical devices, including obtaining and maintaining product approvals and registrations

• Collaborating with internal teams to ensure compliance with regulatory requirements

• Coordinating and tracking product changes with regulatory authorities and international partners

• Coordinating product approvals with regulatory authorities

• Interpreting and implementing relevant national and international regulations

• Approving documents in our document management system

**Requirements**

• Bachelor's degree or equivalent with a focus on quality management, compliance, or a related field

• Minimum 3 years of experience in regulatory affairs, quality management, or a related field, with a focus on medical devices

• Experience with international regulatory processes and technical documentation is an asset

• Proficiency in MS Office software and general computer skills

• Excellent communication and teamwork skills

• Ability to work independently and manage multiple tasks

**What We Offer**

• A dynamic and innovative work environment with a strong focus on teamwork and customer satisfaction

• A competitive salary and benefits package

• Opportunities for professional growth and development

• A collaborative and supportive team environment

• A comprehensive benefits package, including health insurance and retirement plan

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