Product Development Supervisor

hace 2 semanas


Valencia, Valencia, España Vitrolife Group A tiempo completo

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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