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★★★ Regulatory QA Manager (Medical Devices), PharmaLex Bulgaria JSC  Вижте визитка на компанията
Месторабота София; Постоянна работа; Пълно работно време
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Regulatory QA Manager (Medical Devices)

Be a part of our growing company!

Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.

We are looking for motivated, committed candidates who will enjoy working independently within our 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 our successful team.

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.
We are looking for a Regulatory QA Manager to assist the General Manager in managing the facility registration, device listing, licenses, and other quality-related activities.

Your role
► 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.

Your profile
► Bachelor of Science Degree with 3 years of experience in QA/regulatory and process improvement in the biotech industry or equivalent;

► Experience with implementations of QMS, especially in the field of medical devices;

► Knowledge of and direct experience with ISO 13485;

► Fluency in English – both verbal and written;

► Understanding and writing of Technical Files to support Essential Requirements;

► Strong attention to details and ability to work with a high level of accuracy;

► Experience in filling and obtaining CE Mark certificate, especially in the field of medical devices;

► Ability to effectively multi-task, deal with changing priorities.

We offer you:

► 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!

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