At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family.
Together we help our customers and their patients to fulfill the dream of having a baby.We are currently looking for a Product Development Supervisor to join the R&D team.The main purpose of the Product Development Supervisor is to plan and create the Design History File for IGENOMIX Genetic Services products under the supervision of the Product Development Director.Main responsibilitiesCreation 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 ManagementCreate 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 CompetenciesStrategic 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.RequirementsDegree or PhD in Biology, Biochemistry, Biotechnology, Biomedicine or related field.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.
Communication skills.
Ability to work independently.C1 or similar level of spoken and written English.Knowledge of molecular techniques for genetic analysis.
*The interview will be conducted in English.The employee can be based in Valencia or at another subsidiary of the Vitrolife Group.We look forward to receiving your application!Vitrolife Group is a global provider of medical devices and genetic services.
Based on science and advanced research capabilities, we develop services and products for personalised genetic information and medical device products.
We support our customers by improving their clinical practice for the patient's outcome of a fertility treatment.We are currently approximately 1,100 colleagues worldwide, with headquarters in Gothenburg, Sweden.
Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors.
Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF clinics by providing superior products and services with the vision of fulfilling the dream of having a baby.
The Vitrolife share is listed on Nasdaq Stockholm.#J-18808-Ljbffr