We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Director IVD Europe (Regulatory Affairs and Quality Affairs)
- Leading complex consultancy to PharmaLex clients regarding medical devices / IVD development to life cycle management.
- Leading business development activities including involvement in client tenders, meetings, proposal development and quotations.
- Drive commercial success for Clients by ensuring optimal licensing strategy, marketing positioning and regulatory compliance of clients’ products.
- Leading the preparation, revision and maintenance and compilation of product information, technical dossiers and regulatory documentation.
- Responsibility for the working organisation within the department incl. assignment of defined tasks to the employees.
- Presenting seminars and lectures PharmaLex-internally, for customers and for professional audience.
- Coordination of project teams with internal and external staff and Global Alliance Partners as appropriate.
- Contributing to the optimization of the business operations by optimizing resources in projects and leveraging internal processes.
- Actively contributing to the sharing of knowledge within the Medical Device / IVD department.
- Participation in strategic regulatory issues (e.g. Regulatory consultations).
- Providing additional appropriate customer-oriented commercialisation, market access, supply and technical support as required.
- University degree in Science or Engineering.
- Ideally post-graduate qualifications.
- Typically 15 years+ in regulatory and/or quality management in medical device or diagnostics, preferably with consulting experience.
- Profound experience in the evaluation, preparation and compilation of quality/technical documentations and experience in regulatory processes (registration procedures, renewals, variation procedures) in medical devices, diagnostics, biotechnology or consulting environment.
- Experience in leadership position/s and proficient leadership qualities.
- Experience in defining and implementation of processes and rules.
- Basic economic knowledge and experience to efficiently and effectively steer the dedicated projects.
- Capability to analyse problems and to develop possible solutions.
- Capability to motivate employees.
- Capability to professionally represent the department and the company both externally and internally.
- Capability to coordinate different projects to be executed in parallel.
- Professional written and verbal communication skills.
- English language fluency.
- Resilient and adaptable.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.