Beschreibung
Head ofRA/QAFor our client, a leading biotech organization, in antibacterial medical solutions, we are currently looking for a Head of QA/RA. We are seeking a motivated and experienced QA/RA Lead (part-time for 20hrs per
week) to join our team in the medical device industry. As a QA/RA Lead, you will be responsible for ensuring that our products meet the highest quality and regulatory standards. You will play a crucial role in maintaining compliance with industry regulations and driving continuous improvement in our quality assurance and regulatory affairs processes
Employment Type: 12 months temp (50%), then Permanent Employment
Zürich/Amsterdam: mostly remote
Key Responsibilities:
- Develop and implement quality assurance and regulatory affairs strategies and plan
- Lead and manage the QA/RA team, providing guidance, coaching, and support
- Oversee and ensure compliance with all relevant regulations and standards, including FDA, ISO, and other country-specific requirement
- Overall responsibility for the development, implementation and maintenance of the quality management system
- Internal and external audits
- Coordinate and collaborate with cross-functional teams to support regulatory submissions and facilitate product registration or market approval
- Stay abreast of industry trends, regulations, and guidelines to ensure our products remain compliant and competitive
- GMP oversight and compliance of Production and Quality Engineering activities
- Support key changes and improvements in manufacturing relating to product quality
- Ensure all CAPAs under this role's responsibility are completed in compliance with all regulatory and procedural commitments
- Drive key changes and improvements in the Quality assurance and control Systems
Ideal Candidate:
- Bachelor's degree in a related scientific discipline or equivalent experience.
- 5+ years work experience in an ISO 9001/ISO 13485 environment, coupled with a background in Medical Devices Industry
- Profound knowledge of FDA 21 CFR part 820, Medical Device Regulation (MDR ), ISO 13485, ISO 14971, ISO 11137, ISO 10993
- A working knowledge of FDA requirements and managing FDA audits
- Experience in CAPA system management
- Experience in the preparation of Technical Documentation
- Experience with quality management systems and regulatory submissions
- Proven experience leading and managing a team, excellent communication and interpersonal skills
- Detail-orientation with the ability to analyze complex regulations and translate them into practical actions
Ability to coordinate and negotiate with regulatory authorities, notified bodies, and other stakeholders.
Are you ready to build the future? Join our client to transform the medical landscape with pioneering antibacterial solutions.
You are welcome to contact Sabina Keel by e-mail;
We are looking forward to getting to know you!
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.