Regulatory Affairs Specialist (junior) (M/F)

Your role

Reporting to the Quality, Regulatory Affairs and HSE Director and as part of a team of 5 people, your role will consist of ensuring the regulatory compliance of products and materials throughout their life cycle. You will intervene in the management of customer complaints and materiovigilance, the validation of promotional materials in connection with product teams, as well as the regulatory assessment of changes. You will also contribute to regulatory monitoring and ensure exchanges with internal teams, the ZEISS group and, if necessary, with the competent authorities.

Your main missions will be as follows:

• Manage customer complaints and update KPIs
• Act as the interlocutor for field teams, the group and the competent authority if necessary for customer complaints and materiovigilance
• Proceed with the validation of promotional materials
• Validate clinical claims in collaboration with product managers
• Submit materials to the competent authority for authorization
• Proceed with the regulatory assessment of changes and implement the associated steps to guarantee regulatory compliance
• Ensure regulatory monitoring within your scope of activity.

Your profile

• Minimum BAC+5 in Biomedical Engineering (or equivalent)
• Minimum 1 year of experience in Regulatory Affairs / Quality in medical devices
• Clinical experience is an appreciated plus (ophthalmology, dentistry or related field).

What we are looking for

Technical skills

• Mastery of ISO 9001 and ISO 13485 standards as well as European Regulation (EU) 2017/745.

Personal qualities

• Good interpersonal skills and excellent team spirit
• Dynamism and initiative
• Rigor, method and organization in activity management
• Proactive and commitment to assigned missions.

Languages and tools

• Professional English is imperative (level B2/C1/C2)
• IT tools (Office Suite - Excel, Power Point, Word.).