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.
Manager Medical Devices/IVD Europe
- Advising, supporting and managing regulatory, technical and quality management consulting projects for clients in the medical devices and diagnostic sectors.
- Supporting PharmaLex staff and their customers in the implementation of medical devices and diagnostic regulatory strategies.
- Participating in the preparation, revision and compilation of product information (e.g. IFUs, PIL, labels).
- Creating, revising, editing and maintaining technical dossiers and regulatory documentation for clients.
- Communicating with clients and Health Authorities within the scope of assigned projects.
- Actively contributing to the sharing of knowledge within the Medical Device / IVD department.
- Providing support to more senior colleagues in their client-related work, including representation at business development meetings, and marketing activities.
- University degree in Science or Engineering
- 4 + years in regulatory and/or quality management in medical device, diagnostics, biotechnology or related consulting environment.
- Hands-on experience in the preparation of regulatory and technical submissions, reports and documentation or in the implementation of quality management systems (e.g. ISO 13485, ISO 9001, 21 CFR 820, MDSAP or equivalent), preferably in the medical device or diagnostics environment.
- Sound understanding of local and international regulatory and compliance legislation and requirements.
- Ability to efficiently obtain and review information from a range of sources
- Ability to interpret, analyse, plan, write and apply appropriate legislation, regulatory, technical and quality requirements.
- Ability to identify and understand the commercial context and make decisions accordingly
- Ability to prepare regulatory documents and reports that are accurately referenced, with appropriate citation and written in cohesive manner to optimise outcomes
- Complex problem-solving abilities and business orientation
- Structured, analytical and systematic thinking abilities
- Ability to manage multiple tasks and drive project outcomes autonomously
- Team player with collaborative work style and willingness to knowledge share
- Strong customer focus
- Effective written and spoken communication skills with internal and external customers, colleagues and supervisors
- Flexible and adaptable
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English language fluency, written and spoken
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.