Quality Assurance Specialist

vor 1 Tag

Garching an der Alz, Bayern, Deutschland OncoBeta - epidermal radioisotope therapy Vollzeit
Join Our Team as a Quality and Regulatory Compliance Manager

We are seeking a highly skilled Quality and Regulatory Compliance Manager to join our dynamic team at OncoBeta, a leading medical device company. As a key member of our quality management and regulatory affairs department, you will play a critical role in ensuring the compliance of our products with international quality standards.

Key Responsibilities:

  • Assist in the development and implementation of quality management systems (QMS) and regulatory affairs strategies
  • Perform audits and assessments to ensure compliance with quality standards and regulatory requirements
  • Manage and maintain technical documentation for product submissions and changes
  • Collaborate with internal stakeholders and external resources to optimize quality and regulatory processes
  • Track and manage corrective actions and apprise management of their status

Requirements:

  • 4+ years of experience in quality management and regulatory affairs for medical devices
  • Specialist knowledge and application of medical device QMS (ISO 13485 / 21 CFR 820)
  • Experience in risk management of medical devices as per ISO 14971
  • Fluency in English and B2 level of German

About OncoBeta:

OncoBeta is a small but fast-growing medical device company focused on developing and marketing an epidermal radioisotope therapy for non-melanoma skin cancer. We are committed to providing patients with a standard of care that has a high efficacy rate, is non-invasive, painless, and provides positive cosmetic outcomes.

Why Join Us:

At OncoBeta, we offer a dynamic and international work environment with a team of driven individuals. We are committed to innovation, quality, and customer satisfaction. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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