Specialist Regulatory Affairs (m/w/d)
Bremen, Berlin, or Baden-Wuerttemberg
My client, a global leader within the field of medical laboratory diagnostic testing, with a strong focus on molecular test systems, is currently searching for a new Specialist Regulatory Affairs. This is a new position introduced into the department, designed with a view to further enhance the success rate of new product introduction whilst assisting product development.
Within this role, you will truly have the chance to learn from a highly experienced line manager, further develop your skills in the regulatory space, and work within an inclusive, supportive, and dynamic team.
What tasks await you as the new Specialist Regulatory Affairs?
- The worldwide approvals and registrations of IVD products.
- Implementation of conformity assessment procedures for CE-marking.
- Creation and maintenance of technical documentation.
- Communication with sales partners, authorities, and notified bodies.
- Ensuring regulatory conformity in the respective target markets.
- Creation of regulatory and approval-related documents, including regulatory plans and reports, technical dossiers, and change notifications.
- Regulatory assessment of changes.
- Track and evaluate both regulatory and normative changes.
The ideal Specialist Regulatory Affairs should have the following qualifications/skill sets:
- Successfully completed a university degree in a relevant scientific or technical field.
- At least 2 years of working experience in the field of regulatory affairs and/or quality management for medical devices/IVD's.
- Knowledge of essential regulatory-related standards, laws, and guidelines (ISO 13485, ISO 14971, etc.)
- A committed, goal-orientated mindset, coupled with the ability to collaborate and work well in a team environment.
- An independent and structured way of working.
- Strong communication and organisational skills.
- Fluency in both English & German (written and spoken).
With my client, you can expect an interdisciplinary working environment, in an always expanding company. Send your application now to have your chance in working in a highly qualified and committed team!!
Looking forward to receiving your interest.