Our client, a medical device start-up specialized in the development and commercialization of surgical robotics, is looking to strengthen their team with a:
Quality Assurance and Regulatory Affairs Manager (w/m/d)
- In this role, you will be responsible for all quality related tasks and taking full ownership of advancing and maintaining their quality management system while ensuring highest quality standards in product development and manufacturing.
- In addition, you will represent the client in all regulatory affairs.
- You will be part of a collaborative and agile team which is striving to commercialize disruptive technologies.
- You will enjoy a high degree of freedom in how you organise your activities and working hours.
- The QA/RA Manager is a critical role for the company’s vision to grow and directly reports to the company’s CEO.
- Quality representative and responsible for maintaining and advancing the QMS.
- Develop and maintain SOPs, WI and other relevant quality documents.
- Ensure compliance to applicable requirements in the frame of ISO 13485 2016 and lead internal audits.
- Implement and maintain CAPA and Risk Management systems and related processes.
- Support R&D with development, V&V and maintenance of technical files.
- Lead interactions with regulatory bodies, act as Person Responsible for Regulatory Compliance (PRRC)
- Developing regulatory strategies for new products and support compiling technical dossiers.
- Preparation and execution of supplier quality agreements and responsible for supplier audits.
- Data management: archiving and filing of documents and data.
- Implement training system and ensure QMS training of all employees.
- Responsible for pre-clinical and clinical trials and preparation of clinical evaluation reports.
- Self-starter with ability to work independently and in interdisciplinary teams.
- Excellent communication skills across all levels of the company and with suppliers.
- Strong interpersonal skills and collaborate effectively with others.
- Bachelor or Master’s degree in life science, engineering, chemistry, pharmacy or related fields.
- Minimum 5 years’ experience in the medical device industry.
- Minimum 5 years’ experience in a QA or RA role.
- Proven track record in registrations of medical devices in US and EU.
- Current and solid knowledge of FDA 21 CFR part 820, EU MDR 2017/745 and ISO 13485
- ISO 9001:2015 Lead Quality Auditor Certificate / ISO 13485:2016 Lead Quality Auditor Certificate
- Strong planning and organizational skills.
- Proficiency in English and German, French is a plus.