Regulatory Affairs Manager (m/f/d)

REFERENCE NUMBER:

493963/1

MY DUTIES:

- Manage the regulatory activities and supports the product care activities of the assigned (existing and authorized) product portfolio within Centralized and professional diagnostics.
- Assess and communicates regulatory risks and challenges to project teams (no direct contact with the regulatory authorities)
- Consultancy and active support of the R&D project teams during the product lifecycle
- Accomplish conformity evaluation for existing devices also under the in-vitro diagnostics regulation (IVDR)
- Planning of Deliverables with other Regulatory Affairs professionals for product registrations, including compilation of corresponding Software Reports
- Ensure the interface between Regulatory Affairs teams for product approvals/clearances in the various regions and fulfillment of requirements
- Work in a cross-functional, multi-site team to ensure alignment and harmonization

MY QUALIFICATIONS:

- FH or University degree in a scientific/technical discipline
- Significant knowledge of global regulatory processes and proven experience of successful management of regulatory procedures
- In-depth industry-related working experience
- English fluent in written and spoken
- Experiences with software as medical device are beneficial
- Experience in a regulated environment or experience in GxP

MY BENEFITS:

- You will work in an international environment
- Possibilities to work in a home office

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.