Quality Affairs & Regulatory Affairs (ba_FR_OTM_QARA)
Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then you may be a good match for Oticon Medical. Right now, we are looking for a dedicated and highly skilled Global Regulatory Affairs Officer.
Our mission is to improve the life experience for people with profound hearing losses. And we are proud to say that everybody working in Oticon Medical is passionate about making a difference – because to us sound matters.
Our commitment to making a difference
Together with skilled colleagues, you are part of a dynamic environment based on trust and openness, and you will experience a strong passion for our patients. We are a growing international company where everybody supports the business by making sure we successfully bring the best experience to our users. You will be working in a bright and open workplace, where a flexible working environment, knowledge-sharing and professional respect makes it meaningful to go to work. You will find the perfect framework for your professional and personal development in a culture built on trust, openness and mutual respect. We welcome you in a growing international company where we push hard to be at the forefront of what is technically possible. No matter if the goal is a new, highly advanced hearing aid feature, a new ERP system or a totally revolutionary marketing tool, we strive to excel.
In an environment involving high requirements and within the Quality and Regulatory Affairs Department, you will work actively with Sales Companies, distributors and different internal Departments, including Marketing, R&D & Customer Service.
- Responsible for obtention & life cycle management (renewal, changes) of sales authorizations for Oticon Medical CI products:
- preparation of technical & regulatory information according to national regulatory requirements;
- collaboration with R&D, Marketing, Operations Department and Regulatory contacts within the sales companies & distributors;
- legalization and followup of Free Sales Certificates and other documents required for registration within the Chamber of Industry and consulates of targeted countries;
- submission and followup of files within the Sales Companies, distributor and/or Health Authorities.
- Keeping update the dashboard & communication of registration status.
- Continual improvement of processes related to the regulatory field.
- Regulatory monitoring.
- Engineering, Scientific or Pharmaceutical, with Regulatory Affairs degree/ 5 years of experience;
- Proven experience registering products on the international stage;
- Experience working in highly regulated industries such as medical devices or pharmaceuticals;
- Knowledge of European Directives & European regulation related to medical devices;
- Knowledge of quality systems standards such as ISO 13485 and CFR21 Part 820;
- Ability to work actively with multi-disciplinary teams;
- Reactivity, rigor, autonomy, capacity to analyze and synthesize are required skills;
- Good communication skills both written and spoken with French and English;
- Good knowledge at office package (World/Excel/PowerPoint).