Job Description: Quality and Regulatory Manager (Medical Device Company)

Location: Frankfurt am Main, Germany
Type: Full-time (Starting Immediately)

Experience Level: Experienced

Are you familiar with the field of Aesthetics/Medical Devices? Have you always wanted to work in this area?

Then you might be the right person.

NovaCutis GmbH, based in Frankfurt, Germany, is an experienced manufacturer specializing in hyaluronic acid dermal fillers and mesotherapy products.

We specialize in the distribution of aesthetic products for dermatologists, plastic surgeons, and aesthetic physicians, with operations across the globe.

We are currently looking for Quality and Regulatory Manager starting immediately in our office in Frankfurt am Main.

Position Overview:
We are seeking a highly skilled and experienced Quality and Regulatory Manager to lead our Quality Management System (QMS) and ensure compliance with international standards and regulatory requirements within the medical device industry. The ideal candidate will oversee the development, implementation, and continuous improvement of the QMS, while ensuring our products meet the highest standards of safety and quality.

Key Responsibilities:

• Develop, Implement, and Maintain QMS:
• Lead the development, implementation, and ongoing maintenance of the QMS in accordance with international standards, including ISO 13485.
• Ensure that all processes and procedures are compliant with applicable regulations, such as the European Union Medical Device Regulation (MDR).
• Responsible for the development, implementation, and maintenance of the CAPA (Corrective and Preventive Action) procedure to ensure effective resolution of non-conformances and continuous improvement in compliance with regulatory standards.
• Regulatory Compliance and Audits:
• Conduct internal and external audits to assess the effectiveness of the QMS and verify compliance with regulatory standards.
• Manage relationships with regulatory bodies and notify appropriate authorities of any significant quality issues.
• Documentation Management:
• Oversee the creation, revision, and control of quality documentation to ensure compliance and document currency.
• Ensure that all quality documentation is readily accessible and properly maintained.
• Responsible for the creation, update, and maintenance of technical documentation to ensure compliance with current regulatory requirements.
• Training and Support:
• Train and support employees on quality management processes, regulatory requirements, and best practices.
• Ensure that all team members understand and adhere to QMS policies and procedures.
• Process Improvement:
• Analyze QMS processes and recommend improvements to enhance efficiency and product quality.
• Collaborate with cross-functional teams to integrate quality management requirements into day-to-day operations and strategic planning.
• Collaboration and Cross-Departmental Support:
• Work closely with departments such as R&D, manufacturing, and supply chain to ensure QMS requirements are integrated into all business processes.
• Provide guidance on regulatory compliance during product development and lifecycle management.

Requirements:

• Bachelor’s degree in Quality Management, Engineering, Biomedical Engineering, or a related field.
• Proven experience in quality management within the medical device or pharmaceutical industry.
• In-depth knowledge of ISO 13485, MDR, and other international quality standards.
• Experience conducting internal and external audits, with a strong understanding of quality documentation management.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to work collaboratively in a team environment and effectively interact with various departments.
• Strong written and verbal communication skills in English, with proficiency in drafting and reviewing QMS and technical documentation.
• Must be able to work on-site in Frankfurt am Main, with occasional travel as needed.

Preferred Qualifications:

• Experience with regulatory submissions or product certifications for medical devices.
• Familiarity with risk management principles (e.g., ISO 14971).
• Proficiency in German (preferred but not mandatory).

Art der Stelle: Vollzeit

Arbeitszeiten:

• Montag bis Freitag

Leistungen:

• Flexible Arbeitszeiten
• Kostenlose Getränke

Berufserfahrung:

• QMS: 1 Jahr (Erforderlich)

Sprache:

• business English? (Erforderlich)

Arbeitsort: Vor Ort