We are growing, grow with us!
On a brand-new project, we support our client – an innovative Canadian biotech company (specialized in medical devices) with its expansion on the European market. The compamy brings together professionals with extensive experience in design and development of point-of-care medical devices, from early-stage prototyping and reagent development to implementation of specialized manufacturing and quality control processes.
We are looking for a Regulatory QA Manager to assist the General Manager Bulgaria in managing the facility registration, QMS development and implementation, device listing, licenses, and other quality-related activities.
We are looking for motivated, committed candidates who will enjoy working independently within a global and successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join the team.
Regulatory QA Manager (Medical Devices)
- Ensure that manufacturing processes comply with standards at both national and international level
- Determine, agree and implement the Quality Management System for the local production
- Ensure that the quality policies adopted by a company are followed;
- Help to identify and prepare the necessary SOPs relative to the processes of quality;
- Determine that the product meets all the applicable specifications and that it was manufactured according to the internal standards of GMP;
- Support the company with the implementation of ISO 13485 and technical documentation for obtaining CE marking certificate;
- Continuously evaluate operations to advise and direct full compliance with all applicable internal and external regulations;
- Conduct internal and external audits to measure compliance with relevant standards, regulations, and policies;
- Provide QA-related training to the team and external clients/partners.
- Bachelor of Science Degree or Technical Education degree
- At least 3 years of experience in QA/regulatory and process improvement in the biotech industry or equivalent;
- Proven record in QMS implementation in the field of medical devices, pharma or related
- Knowledge of and direct experience with ISO 13485;
- Fluency in English – both verbal and written;
- Very good understanding of Technical Files/issues to support Essential Requirements
- Strong attention to details and ability to work with a high level of accuracy;
- Practical experience in filling and obtaining CE Mark certificate, especially in the field of medical devices;
- Ability to effectively multi-task, deal with changing priorities.
- Opportunity to conquer exciting and varied challenges alongside a talented team
- Flexible working hours
- Open and collaborative organizational culture with an emphasis on knowledge-sharing
- Business interaction with nearly all branches of the company across 5 continents
- A broad range of initiatives for personal development and professional training.
If you are interested to take up the challenge at our future-oriented company and would like to grow together with us, send us your CV and Cover Letter (optional) We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!