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Head of Regulatory and Quality Affairs

vor 2 Monaten

Munich, Bayern, Deutschland Aspire Life Sciences Search Vollzeit
Job Summary

Aspire Life Sciences Search is seeking a highly experienced and skilled Head of Regulatory and Quality Affairs to lead our client's regulatory and quality initiatives across all product lines. This is a critical role that will play a key part in ensuring compliance with both EU and US regulatory requirements, overseeing product registrations, and developing and implementing robust quality management systems.

Key Responsibilities
  • Regulatory Strategy and Compliance
    • Develop and implement a comprehensive regulatory strategy to ensure compliance with EU and US regulatory requirements.
    • Lead the submission process for product registrations in the EU and US markets.
  • Quality Management System
    • Develop and maintain a robust quality management system (QMS) to meet international standards.
    • Ensure that products meet regulatory and quality requirements through collaboration with cross-functional teams.
  • Regulatory Affairs and Quality Management
    • Provide leadership and mentorship to the regulatory and quality teams.
    • Monitor and interpret regulatory changes and trends to ensure the company remains compliant and competitive.
  • Audit and Inspection Management
    • Manage audits and inspections by regulatory authorities and customers.
Requirements
  • Education
    • Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs).
  • Experience
    • Extensive experience in regulatory affairs and quality management within the MedTech industry.
    • Proven track record of successful regulatory submissions in both the EU and US.
  • Skills
    • In-depth knowledge of EU MDR, FDA regulations, and ISO standards.
    • Strong leadership skills with the ability to manage and develop a team.
    • Excellent communication and interpersonal skills, with the ability to work collaboratively across departments.
What We Offer
  • Competitive Salary and Benefits
  • Opportunity to Work with Cutting-Edge Technology
  • Collaborative and Innovative Work Environment
  • Potential for Professional Growth and Development