Quality and Regulatory Specialist

**Job Summary**:
**About us**:
Founded in 1970, DRG specializes in the development and manufacture of innovative in vitro diagnostics and medical devices. Our products are successfully marketed through a network of DRG subsidiaries and distributors in more than 110 countries, helping to improve and save lives every day.

In Germany, DRG has been present in Marburg since 1973 with more than 50 employees in the areas of research and development, manufacturing, sales and logistics. DRG Instruments GmbH is an ISO 13485 certified company. In all our considerations and actions, the health and well-being of people are the focus.

**Responsibilities**:

- Ensure regulatory compliance on labeling, including Safety Data Sheets (SDS), Instructions for Use (IFU), and product manuals.
- Support and participate in nonconformance and Corrective and Preventive Actions (CAPA) processes.
- Oversee and support the complaints handling process, ensuring timely resolution and appropriate documentation.
- Assist in the implementation and maintenance of document control systems to ensure accuracy and availability of controlled documents.
- Support the release of Device History Records (DHR) in compliance with regulatory requirements.
- Collaborate with cross-functional teams to establish and maintain a robust supplier compliance program.
- Assist in post-market surveillance activities, including monitoring of product performance, adverse events, and customer feedback.
- Stay up to date with relevant regulatory requirements and industry standards in IVD industry.
- Provide guidance and training to internal teams on regulatory compliance matters.
- Collaborate with regulatory authorities and notified bodies during inspections and audits.
- Contribute to continuous improvement initiatives, suggesting and implementing enhancements to quality and regulatory processes.
- Prepare reports and presentations on quality and regulatory performance for management review.

**Qualifications**:

- Bachelor's degree or higher in Biotechnology, Biochemistry, Chemistry, or a related field. Advanced degree preferred.
- Proven work experience in a quality and regulatory role, preferably in the IVD or medical device industry.
- In-depth knowledge of regulatory standards and guidelines, such as ISO 13485, IVDD, IVDR and relevant regional requirements (e.g., FDA regulations)
- Experience in ensuring compliance with labeling regulations and requirements.
- Understanding of post-market surveillance activities and adverse event reporting.
- Excellent problem-solving and analytical skills, with a keen attention to detail.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across teams.
- Ability to work independently, prioritize tasks, and meet deadlines.

**Familiarity with**:

- Nonconformance, CAPA, and complaints handling processes.
- Document control practices and systems
- Device History Records (DHR) and their release process
- Supplier compliance programs and supplier quality management

**We offer**:

- A permanent position after a successful probationary period.
- The possibility of salary conversion in favor of a job bike.
- Various employee bonus programs (e.g. employee referal, recognition program)
- We are happy to support you with various further training opportunities
- Employer-sponsored lunches & tax-free non-cash benefits through bonus cards (Edenred).
- A friendly and open working atmosphere characterized by respectful interaction with each other
- An international corporate culture.
- Development opportunities in a successful and steadily growing company

Art der Stelle: Vollzeit

Gehalt: ab 2.500,00€ pro Monat

Arbeitszeiten:

- 8-Stunden-Schicht

Sprache:

- German (Erforderlich)

Arbeitsort: In person