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!