ENGINEER WITH REGULATORY FUNCTIONS

Описание

At Manpower Bulgaria, we are looking for a motivated professional for a

Regulatory Affairs Engineer

position, to join a global company specialized in the production of medical and orthopedic solutions.

We are looking for a Regulatory Affairs Specialist with an engineering background or education. The ideal candidate would be a self-driven, proactive, and hands-on individual with strong knowledge and a proven track record.

Main tasks:
Implementation of regulatory requirements in the course of product development projects and changes to existing medical devices;
Preparation, compilation and continuous updating of registration documents and approval dossiers according to country-specific requirements;
Adaptation and maintenance of market approval dossiers to the requirements of the Medical Device Regulation (MDR) 2017/745;
Interaction with authorities, certification bodies, cooperation partners, external service providers and international regulatory affairs contacts;
Participates in the development of regulatory strategies and the processing of global approvals for medical devices as well as receiving these approvals throughout the product lifecycle;
Willingness to travel as part of the onboarding process, or in a reduced form afterwards.

Qualifications:
Completed technical education in mechatronics, electronics, mechanical engineering or similar;
Relevant professional experience in the QM or RA field of a technical company, preferably medical device technology;
Experience with the approval of medical devices and skills in dealing with authorities;
Self-driven, proactive, and hands-on individual with strong knowledge and proven track record.
Project Management experience;
Very good written and spoken English skills;
Good written and spoken German skills – an advantage;
Analytical and solution-oriented thinking and sense for pragmatic solutions;
Social competence, ability to work in a team as well as goal-oriented, independent and assertive way of working.

The company offers:
An attractive remuneration package;
Work place type - hybrid;
The unique opportunity to apply your professional expertise in a challenging environment and build up processes from the scratch;
The chance to acquire valuable competencies in the presence of high-quality standards;
Long-term employment and career path.
If you feel up to the challenge, please apply for this position by sending your detailed CV in English.

If you feel up to the challenge, please apply for this position by sending your detailed CV in English.

Manpower Bulgaria has License № 2033/20.04.2016 for providing human resources services.

Изисквания към кандидата

Езикови познания:
Английски език

Трудов опит:

Образование:

Ние предлагаме

Вид заетост:
Пълен работен ден

Срок на заетост:
Постоянна

Договор:

Ниво в йерархията:

Категория:

ИТ и Компютърни специалисти

Държава:

България

Населено място:

Гр. София

Адрес:

гр.София, ул.Никола Мирчев №33

Дата:

21.06.2024

Организация:

Менпауър България ООД
Агенция за подбор на персонал

Детайли за организацията:

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