Löydä lähin jakelijasi

Sijainti:
Tyyppi:
Tekstihaku:
Username:
Password:
Forgot password?

Työpaikkoja

CLINICAL QUALITY SPECIALIST
Helsinki, Suomi

PROJEKTIPÄÄLLIKKÖ
Helsinki, Suomi

CLINICAL QUALITY SPECIALIST

Helsinki, Suomi
09.05.2018 - 15.06.2018

Located in Helsinki, the CLINICAL QUALITY SPECIALIST will be a key player in the Quality and Regulatory function of Biohit Oyj. You will be recognized by all stakeholders as the expert within the area of product risk management and clinical/performance evaluation.

The CLINICAL QUALITY SPECIALIST reports to the Quality and Regulatory Affairs Director

MAIN ACTIVITIES AND RESPONSIBILITIES:

• Plan, coordinate, and implement clinical/performance evaluations to ensure compliance of Biohit products and technologies
• Ensure total compliance to applicable rules and regulations (IVDR, MDR, study protocols, internal regulations, national and industrial regulations etc.) for performing clinical studies
• Perform documentation, identify clinical best practices and work with stakeholders to improve processes
• Coordinate meetings, documentation reviews and facilitate action items related to product risk management, planning activities, and development for R&D
• Work as a main resource at post-market related activities (e.g. PMCF, PMS, PSUR)
• Support compliance with IVDD/IVDR, MDD/MDR, ISO 9001, ISO 13485, ISO 14001 requirements, and other relevant international regulations
• Coordinate activities related to the CAPA system
• Plan and conduct internal audits
• Support product registrations

IDEAL QUALIFICATIONS

• Relevant university degree in e.g. biochemistry
• Proven experience in clinical/performance evaluation analysis and product risk management
• Experience in medical device regulations
• Consistent follow through on actions and decisions, results-driven, execution-focused and detail-oriented
• Eager to succeed, aptitude for continuous learning
• Superior interpersonal skills, including the ability to create and sustain relationships with leaders
• Excellent verbal and scientific written skills, outstanding presentation skills
• Excellent command of Finnish and English
• You enjoy finding novel solutions to novel problems
• You enjoy working in a fun, fast-based team environment while demonstrating flexibility and dynamism

Please send your cover letter, CV and salary request to Daniela Söderström, daniela.soderstrom@biohit.fi. The application deadline is 31.5.2018.

Henkilötiedot

Etunimi *
Sukunimi *
Sähköpostiosoite *
Puh.
Maa *

Hakemuksen tiedot

Haluan työskennellä *
Erikoisosaaminen
Lataa CV (pdf/doc/docx/rtf/txt)
Muuta