Regulatory Affairs Manager

il y a 2 semaines

Herstal, Belgique SYNOLYNE PHARMA Temps plein

**Objectives / Purpose**:

- The Regulatory Affairs Manager is responsible for leading the regulatory strategy from preparation of registration dossier to post-market follow-up in order to achieve development and marketing goals for medical devices. He/She leads, in collaboration with other departments, the activities related to market authorization, registration and vigilance. The Regulatory Affairs Manager is under the supervision of the Chief Operating Officer. _

**Responsibilities**:

- Support and provide guidance on regulatory issues to internal and external persons on assigned projects.
- Execute or support the preparation and maintenance of new and existing documents required for regulatory approval for assigned projects.
- Gain and maintain regulatory authority approval and manage follow up post-approval activities, including vigilance-related activities, for assigned projects.
- Liaise with regulatory authorities, including notified bodies, as required.
- Participate to product change control activities. - Monitor legal and regulatory related issues for medical devices, as well as progression in standardization work.
- Report to the upper management on any regulatory update or issue impacting the company activities.
- Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards

**Profil**:
**Profile**:

- . University degree (Master or Ph.D) with a scientific (preferably medical or pharmaceutical) or regulatory affairs orientation.
- . 5-years' experience in regulatory affairs.
- . Possessing a strong knowledge, understanding and experience concerning European regulations and quality systems for medical devices (MDR 2017/745 et ISO 13485). Knowledge and relevant experience in other territories (US, China, Brazil) or regulation for medicines (Directive 2001/83, GMP) will be regarded as an additional advantage.
- . Strong communication and organizational skills. In addition, you are accurate, selfdisciplined, proficient in multitasking and a real team player.
- Ability to analyze and summarize scientific and technical information.
- . Ability to work across function and in a changing environment.
- . Strong oral and written communication skills in English and French. A proficiency in other languages will be regarded as an advantage.

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