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!