Quality and Regulatory Specialist

vor 5 Monaten

Marburg an der Lahn, Deutschland DRG Instruments GmbH Vollzeit

Job Overview:
Enterprise

DRG was founded in 1970 and specializes in the development and manufacture of innovative in vitro diagnostic 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, production, sales and logistics. DRG Instruments GmbH is an ISO 13485 certified company. In all our deliberations and actions, people's health and well-being are at the heart of everything.

Your tasks:

- They ensure compliance with regulatory requirements for labeling, including Safety Data Sheets (SDS), Instructions for Use (IFU) and product manuals.
- They assist in the non-compliance and corrective and preventive actions (CAPA) processes.
- They monitor and support the complaint process and ensure a timely resolution and appropriate documentation.
- They assist in the implementation and implementation of document management systems to ensure the accuracy and availability of the controlled documents.
- Support the release and approval of Device History Records (DHR) in accordance with regulatory requirements.
- You'll work with cross-functional teams to establish and maintain a robust supplier compliance program.
- They assist with post-market monitoring activities, including monitoring product performance, adverse events, and customer feedback.
- You will stay up-to-date on relevant regulatory requirements and industry standards in the IVD industry.
- They provide guidance and training to internal teams on regulatory compliance issues.
- They cooperate with regulators and notified bodies on inspections and audits.
- You will contribute to continuous improvement initiatives and propose and implement improvements to quality and regulatory processes.
- You will prepare reports and presentations on the management review.

Qualifications:

- Bachelor's degree or higher in biotechnology, biochemistry, chemistry, or a related field. Advanced degree preferred.
- Proven professional experience in a quality and regulatory function, preferably in the diagnostics 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.
- Understand post-market surveillance activities and adverse event reporting.
- Excellent problem-solving and analysis skills with great attention to detail.
- Strong communication and interpersonal skills, as well as the ability to collaborate effectively across teams.
- Ability to work independently, prioritize tasks, and meet deadlines.

Familiar with:

- Non-conformity, CAPA and complaint processes.
- Document control and systems
- Device History Records (DHR) and their release process
- Supplier Compliance Programs and Supplier Quality Management

What we offer
- A permanent position after a successful probationary period.
- Possibility of salary deferral in favor of a job bike.
- Various employee bonus programs (e.g., employee referral, recognition program)
- We are happy to support you with various further training opportunities
- Employer-sponsored lunches and tax-free benefits in kind 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

Arbeitszeiten:

- Montag bis Freitag

Leistungen:

- Empfehlungsprogramm
- Essenszuschuss
- Flexible Arbeitszeiten
- Kostenlose Getränke

Arbeitsort: Vor Ort

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