Product Development Supervisor
hace 2 semanas
Job Title: Product Development Supervisor
About the Role:
We are seeking a highly skilled Product Development Supervisor to join our R&D team at the Vitrolife Group. As a Product Development Supervisor, you will be responsible for planning and creating Design History Files for IGENOMIX Genetic Services products under the supervision of the Product Development Director.
Main Responsibilities:
- Creation and maintenance of Design History Files and Technical Files for genetic services in accordance with international regulations (EU IVD-R, USA FDA, JP PMDA, etc.).
- Creation of application documents in accordance with ISO13485, ISO15189, IEC62304, etc.
- Support for application of program medical devices (Laboratory process + Analysis program + Portal) to Japanese regulatory authorities.
- Documentation Management: Create technical documentation to comply with local regulations in countries where IGX services are offered.
- Engage with local teams to identify regulatory requirements.
- Back-up of the person responsible for regulatory compliance within the IVDR standard.
- Management of control of change processes.
- Planning and monitoring of Post-Market Performance Follow-up.
- Supervision of personnel.
Special Competencies:
- Strategic Awareness: Regularly reviews and adjusts plans, sets challenging goals, focuses on priorities, and commits to company objectives.
- Professional Excellence: Manages tasks effectively, adapts to change, strives for continuous improvement, and maintains focus under pressure.
- Communication: Provides clear, objective information, encourages open dialogue, and listens to others' perspectives.
- People Focus: Builds trust, motivates others, takes responsibility for team actions, provides feedback, and listens to team concerns.
- Integrity & Ethical Work: Keeps commitments, acts with honesty and fairness, takes responsibility for decisions, and aligns actions with company values.
Requirements:
- Degree or PhD in Biology, Biochemistry, Biotechnology, Biomedicine or related.
- Five years experience in IVD product development, regulatory submissions and obtaining regulatory approvals in IVD company and/or experience in QMS for IVD products as RA/QA in IVD company.
- Previous experience as a supervisor, operations manager, diagnosis manager or technical manager in a genetic analysis laboratory.
- Demonstrable experience and competence in project management tasks, planning, time management and organization skills.
- Ability to manage people teams, strong communication skills, and ability to work independently.
- C1 or similar level of spoken and written English.
- Knowledge of molecular techniques for genetic analysis.
Language: The interview will be conducted in English. The employee can be based in Valencia or at another subsidiary of the Vitrolife Group.
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