Head of Regulatory and Quality Affairs
Vor 4 Tagen
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.
- 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.
- Competitive Salary and Benefits
- Opportunity to Work with Cutting-Edge Technology
- Collaborative and Innovative Work Environment
- Potential for Professional Growth and Development
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Director of Regulatory and Quality Affairs
vor 1 Woche
Munich, Bayern, Deutschland Aspire Life Sciences Search VollzeitJob SummaryAspire Life Sciences Search is seeking a highly experienced and skilled Director 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,...
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Director of Regulatory and Quality Affairs
vor 1 Woche
Munich, Bayern, Deutschland Aspire Life Sciences Search VollzeitJob SummaryAspire Life Sciences Search is seeking a highly experienced and skilled Director 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,...
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