Arznei- und Lebensmittelrecht, Medizinprodukte-, Apotheken- und Medizinrecht

Arznei- und Lebensmittelrecht, Medizinprodukte-, Apotheken- und Medizinrecht

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  • Frank Seipel
    Frank Seipel    Premium Member   Group moderator
    The company name is only visible to registered members.
    2 amazing RA devices/ implants positions
    My client develops and manufactures several different kind devices/implants that are connected to hearing loss.
    The company is a fast growing medical device enterprise with presence in all major global markets and they have TWO open positions in the area of regulatory Affairs.

    Their state-of-the-art implantable hearing systems have enriched the lives of thousands of children and adults in over 80 countries world-wide.

    Their team numbers over 500 people globally, with headquarters in Innsbruck, Austria, and 15 international offices. To support continuing growth, they are currently offering the positions listed below

    1.) Manager of Regulatory Compliance and Surveillance

    Job Description:
    - Responsible for establishing and maintaining procedures which ensure proper complaint processing and vigilance reporting in accordance with applicable statutory requirements for medical devices around the world for our products.
    - Supervises personnel to both actively and passively compiles information on product field performance and evaluates the information according to regulations and company procedures for post market surveillance as required by regulatory requirements.
    - The focal point for driving improvements to the quality system processes in the areas of complaint processing, incident reporting, and post market surveillance which lead to robust, efficient, and compliant processes.
    - Reports to Corporate Director, Regulatory Affairs and Quality Assurance.

    Qualification and skills:
    - knowledge and demonstrated proficiency in complaint processing, incident reporting, and post market surveillance
    - perfect English skills necessary

    2.) Regulatory Affairs Specialist

    Job Description:
    - The focal point for development, preparation, and submission of applications and notifications to international regulatory agencies and governing bodies, as assigned.
    - Provides input to product development projects and changes to existing products regarding regulatory requirements and related company requirements.
    - Provides input to the development of regulatory strategies and obtaining regulatory approvals from international regulatory agencies, as required throughout the product life cycle.
    - Reports to Manager, Regulatory Affairs

    Qualification and skills:
    - knowledge and demonstrated proficiency in the field of Regulatory Affairs and medical device
    - perfect English skills necessary

    The status as a private company is very important to their identity. Being private allows them to focus on further developing new products and technologies regardless of changes in international financial markets and short-term financial goals.


    For further information about this great opportunity or other Regulatory Affairs jobs, please do not hesitate to contact me at Real Pharma Frankfurt on +49 (0) 69 26 489 8400.
    • 07 Jul 2009, 2:08 pm