Quality and Regulatory Affairs Manager (Medical Devices)

от 1 500 до 2 500 USD на руки

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Требуемый опыт работы: 1–3 года

Полная занятость, гибкий график

Our startup has secured funding to get product to the market and we are looking for a stellar Quality and Regulatory Manager to help with that task. It is a critical position to fill in and we want to reward such person with various benefits, including above market salary, flexible hours and travel opportunities.

Skills and Requirements:

  • University degree in medicine, biological science, engineering, or related area;

  • At least one year of professional experience in quality management or regulatory affairs related to medical devices (experience with attaining CE marking for Class II devices and/or building QMS from ground up and/or conducting audits is a huge plus);

  • Practical knowledge of ISO 14971, ISO 13485, GCP, IEC 60601, Biocompatibility and other applicable protocols related to medical device manufacturers and/or consumer medical devices;

  • Good grasp of statistics (experience in biostatistics in clinical research is a huge plus);

  • Capability of working with limited supervision, to set priorities to meet timelines, and to motivate and influence others;

  • Strong evaluative, analytical, and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions.

Tasks / Responsibilities:

  • Development of a strategy for establishing company / product conformity with ISO 13485 in a way that complies with all necessary requirements yet accounts for flexible nature of a startup;

  • Ongoing supervision and active hands-on support in ISO 13485 implementation (including documents creation and maintenance);

  • Full governance of CE marking for Class I/II products (software and hardware): selecting Notified Body, preparing technical files, formulating strategy related to product claims, communicating with researchers across Europe regarding protocols, end-points and sample size of clinical studies that will form part of the Clinical Evaluation Report, submitting documents, registering product on the market, etc.;

  • Establishing and maintaining processes for market surveillance and reporting;

What opportunities are there?

  • Learn from and work with a renowned Germany consultancy team, whose members are part of IEC 62366 standards committee, have secured hundreds of clearances without a failure, worked with startups and Big Pharma alike and are just super friendly and responsive. They will provide templates for technical files / QMS, supervise / assist in filling in and implementing those, as well as prepare our company for audits;

  • If you live in Belarus and are involved in regulatory affairs, this is probably the best opportunity to get exposed to novel diagnostics using smartphones, neural networks and very simple devices that can solve $7B+ problem of avoidable hospitalisations;

  • Our aspirations do not stop at CE level. After obtaining first regulatory clearance, you can be responsible for global regulatory strategies spanning from Asia to US;

Work conditions:

  • Flexible working hours (as long as job is done and you are generally available);

  • Transparent salary (all paid to your credit card), paid sick leaves;

  • You choose a laptop you want to work on;

  • We are frequent participants / presenters at both startup and scientific conferences across Europe (soon expanding to other parts of the world). If you want to dive a bit deeper into communication with various stakeholders - welcome!

  • Health insurance (upcoming);

 Доступно соискателям с инвалидностью 

Ключевые навыки

EngineeringMedical devicesISO 13485Clinical ResearchQMSRegulatory affairsStatisticsCE mark

Адрес

Уручье, Минск, Стариновская улица, 3
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Вакансия опубликована 18 мая 2019 в Минске

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