Quality Assurance Specialist

21 uur geleden

Breda, Noord-Brabant, Nederland ZEISS Group Voltijd
Job Title: Quality & Regulatory Specialist

ZEISS Group is seeking a highly skilled Quality & Regulatory Specialist to join our team in the Benelux region. As a key member of our organization, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities:
  • Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and mitigate quality and regulatory risks.
  • Provide training and support to employees on quality and regulatory procedures.
  • Manage and maintain documentation related to quality and regulatory compliance.
  • Develop and implement communication strategies to promote quality and regulatory awareness across the organization.
  • Coordinate internal audits and external certification audits.
  • Manage reimbursement of products and technologies in local markets.
  • Liaise with external agencies on changes in local regulations and communicate accordingly within the organization.
  • Cover Medical Device Regulations (MDR) and quality-related questions coming from the market and liaise with HQ on these topics.
  • Provide information and training to employees on regulatory requirements and changes in regulations.
Requirements:
  • Bachelor's or Master's degree in a relevant field (e.g., life sciences, engineering, or law).
  • At least 4 years of experience in quality and regulatory roles in the medical device industry.
  • Strong knowledge of EU-MDD and EU-MDR regulations.
  • Excellent communication and project management skills.
  • Fluent English and Dutch language skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer:
  • An attractive salary and annual bonus.
  • Holiday allowance and 25 days of paid leave.
  • Training and development opportunities.
  • A dynamic and interdisciplinary work environment.
  • Flexibility and vitality in our locations.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are passionate about quality and regulatory compliance and want to join a dynamic team, please submit your application.

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