Regulatory Affairs Manager M CDI H/F Nemera

Required profile:

- Master's degree or higher in life sciences or sciences (Pharmacist, Master in Regulatory Affairs).
- At least 8 years of professional experience (Combination Products)
- Experience in managing and developing teams
- Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environment.
- Experience in leading Regulatory & Compliance projects in transversal projects
- Experience in quality management system and GMP
- Advanced knowledge and experience in ISO 11608, ISO 23908, ISO 14971, awareness of IEC 60601-1, IEC 62304
- Knowledge of the process of medical device design with products such as syringes, pen injectors, autoinjectors, infusion pumps
- Good English speaking and written
- International committee experience

Soft skills:

- Effective interpersonal skills with ability to work in a team or independently.
- Ability to multi-task and manage priorities with effective organizational and time management skills
- Demonstrated flexibility and adaptability.
- Highly motivated with a proactive approach to learning and problem solving
- Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
- Analytical and synthetical skills

Some travels are required. We offer the possibility of working from home 2 days per week.

• Carte tickets restaurants
• Équilibre vie pro - vie perso grâce aux 2 jours de télétravail/semaine
• Opportunités d’emploi variées au sein d'un groupe international

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients' lives.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net

Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!

Chez Nemera, nous valorisons la diversité et l'inclusion et nous nous engageons à créer un environnement de travail où tous les employés sont traités avec dignité et respect.
Nous sommes fiers d'être un employeur offrant l'égalité des chances et nous encourageons les candidatures de toutes les origines, genres, orientations sexuelles, âges, et capacités.