Филтри
Regulatory Affairs Specialist
At Manpower Bulgaria, we are looking for a motivated professional for a
Regulatory Affairs Specialist
position, to join a global company specialized in the production of medical and orthopedic solutions.
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.
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.
If you feel up to the challenge, please apply for this position by sending your detailed CV in English.
Thank You!
