Regulatory Compliance Specialist
vor 2 Monaten
Job Overview
The position of Global Quality Systems Manager is responsible for ensuring corporate compliance to all applicable regulations, including cGMP. As part of the leading quality assurance function for the Corporate Quality system, the job holder will actively provide guidance to multiple departments and sites regarding compliance to the applicable SHL Corporate Quality and Regulatory procedures, including Agency policies and regulations.
Main Responsibilities:
- Develop and maintain the corporate Quality Management System (QMS).
- Lead Corporate Quality Assurance and Regulatory Affairs (QARA) projects.
- Lead and manage corporate quality audits, ensuring compliance with internal and external standards.
- Provide guidance and best practices on site-specific QMS implementation.
- Lead and participate in internal and external audits at various sites.
- Deliver quality-related training sessions to relevant stakeholders.
- Organize and facilitate corporate Management Reviews.
- Track, analyze, and report on Corporate Key Performance Indicators (KPIs).
Minimum Requirements:
- At least 5 years of experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance within the medical device industry.
- Proven track record of success and a broad understanding of contemporary quality practices applicable to product development, manufacturing, and commercial operations.
- Demonstrated expertise in designing and implementing quality processes within a medical device manufacturing environment.
- Strong self-confidence and the ability to effectively engage with all levels of the organization.
- Excellent problem-solving and decision-making skills.
- Commitment to operating with the highest standards of ethics and integrity.
- Ability to understand, respect, and adapt to different cultures and market needs.
- Excellent English communication skills, both oral and written.
Preferred Qualifications:
- Advanced leadership and team management skills.
- In-depth knowledge of Good Manufacturing Practices (GMP) and other regulatory compliance requirements.
- Proficiency in German, both oral and written.
Education and Training:
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- Certified Lead Auditor for ISO 13485 standards.
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